Trial Outcomes & Findings for Maternal Role in Oral Feed Establishment in Preterm Neonates (NCT NCT05484726)
NCT ID: NCT05484726
Last Updated: 2024-12-02
Results Overview
Time interval between commencement of perioral sensory stimulation on D1 to establishment of full oral feed in both groups. It was done daily till 14th day of perioral sensory motor stimulation. Transition time to full oral feeding was the day at which baby was able to take oral feed of volume of 120-140ml/kg/day.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
130 participants
Primary outcome timeframe
Expected time of oral feed establishment
Results posted on
2024-12-02
Participant Flow
The study period spans 16 months (March 2022 - July 2023), in the department of Neonatology, Fatima Memorial Hospital, Lahore. All preterm of gestation age 28 to 34 weeks, admitted to NICU during the study period after seeking consent from parents or guardians were enrolled. All neonates having major anomalies incompatible with life, cleft lip and palate, genetic disorders, IVH (grade III \& IV), HsPDA, hemodynamic instability, NEC (stage II \& III) or anemia requiring transfusion were excluded.
Out of 142 eligible neonates, study was started with 130 as 65 in each group. Twelve neonates were excluded as 2 mothers experienced serious postnatal complications, 1 instance of parental refusal after initial participation, 1 case with incomplete data, and 8 others. Out of 65 neonates in each group, in 49 from intervention group and 48 from control group, sensory motor stimulation could be performed per protocol as 33 total neonates were excluded and details have been mentioned in table.
Participant milestones
| Measure |
Intervention Group (Group 1)
* Maternal involvement was done in three stages for the intervention group as
o Observer status
* Performing under supervision
* Independent
* Study groups for sensory motor stimulation (5 minutes) + pacifier (2 minutes)
Intervention group (Group I): by mothers
1. T1: Nurses performed all steps while mother observer status
2. T2: Nurses performed all steps in front of the mother and a pacifier was offered by the mother
3. D1: Mother performed all steps and oral milk was offered by the nurse while the mother observed.
4. D2: Mother performed all steps and offering oral milk under nurse supervision
5. D3: Mother performed all steps independently
perioral sensory motor stimulation: Step 1 - 6 over 5 minutes
1 With the help of the index finger, on the external surface of the cheek, make a circle starting from the angle of the mouth towards the ear then back 7x each cheek
2 While holding both sides of the cheek with help of the thumb and index finger repeat step 1 7x each cheek
3 Move index finger from one corner to opposite one over both lips separately 7x each lip
4 Gentle massage and compress the gums from center to back of mouth 7x each half of the gum
5 Move the finger from front to back on the hard palate while applying gentle pressure 7x
6 Displace the center of the tongue with gentle pressure 7x
7 Offer pacifier at the end 2 minutes
Note: 7x means 7 times
|
Control Group (Group 2)
All steps were the same as the intervention group and were performed by staff nurses
perioral sensory motor stimulation: Step 1 - 6 over 5 minutes
1 With the help of the index finger, on the external surface of the cheek, make a circle starting from the angle of the mouth towards the ear then back 7x each cheek
2 While holding both sides of the cheek with help of the thumb and index finger repeat step 1 7x each cheek
3 Move index finger from one corner to opposite one over both lips separately 7x each lip
4 Gentle massage and compress the gums from center to back of mouth 7x each half of the gum
5 Move the finger from front to back on the hard palate while applying gentle pressure 7x
6 Displace the center of the tongue with gentle pressure 7x
7 Offer pacifier at the end 2 minutes
Note: 7x means 7 times
|
|---|---|---|
|
Overall Study
STARTED
|
65
|
65
|
|
Overall Study
Execution of Sensory Motor Stimulation
|
54
|
53
|
|
Overall Study
COMPLETED
|
49
|
48
|
|
Overall Study
NOT COMPLETED
|
16
|
17
|
Reasons for withdrawal
| Measure |
Intervention Group (Group 1)
* Maternal involvement was done in three stages for the intervention group as
o Observer status
* Performing under supervision
* Independent
* Study groups for sensory motor stimulation (5 minutes) + pacifier (2 minutes)
Intervention group (Group I): by mothers
1. T1: Nurses performed all steps while mother observer status
2. T2: Nurses performed all steps in front of the mother and a pacifier was offered by the mother
3. D1: Mother performed all steps and oral milk was offered by the nurse while the mother observed.
4. D2: Mother performed all steps and offering oral milk under nurse supervision
5. D3: Mother performed all steps independently
perioral sensory motor stimulation: Step 1 - 6 over 5 minutes
1 With the help of the index finger, on the external surface of the cheek, make a circle starting from the angle of the mouth towards the ear then back 7x each cheek
2 While holding both sides of the cheek with help of the thumb and index finger repeat step 1 7x each cheek
3 Move index finger from one corner to opposite one over both lips separately 7x each lip
4 Gentle massage and compress the gums from center to back of mouth 7x each half of the gum
5 Move the finger from front to back on the hard palate while applying gentle pressure 7x
6 Displace the center of the tongue with gentle pressure 7x
7 Offer pacifier at the end 2 minutes
Note: 7x means 7 times
|
Control Group (Group 2)
All steps were the same as the intervention group and were performed by staff nurses
perioral sensory motor stimulation: Step 1 - 6 over 5 minutes
1 With the help of the index finger, on the external surface of the cheek, make a circle starting from the angle of the mouth towards the ear then back 7x each cheek
2 While holding both sides of the cheek with help of the thumb and index finger repeat step 1 7x each cheek
3 Move index finger from one corner to opposite one over both lips separately 7x each lip
4 Gentle massage and compress the gums from center to back of mouth 7x each half of the gum
5 Move the finger from front to back on the hard palate while applying gentle pressure 7x
6 Displace the center of the tongue with gentle pressure 7x
7 Offer pacifier at the end 2 minutes
Note: 7x means 7 times
|
|---|---|---|
|
Overall Study
Protocol Violation
|
3
|
3
|
|
Overall Study
failure to establish gavage feed by 2 weeks of chronological age
|
4
|
2
|
|
Overall Study
HsPDA requiring antifailure therapy
|
1
|
2
|
|
Overall Study
continued need of mechanical ventilation
|
2
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
|
Overall Study
IVH (G III & IV)
|
2
|
1
|
|
Overall Study
NEC (stage II & III)
|
2
|
3
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Intervention Group (Group 1)
n=49 Participants
Maternal involvement was done in three stages for the intervention group as
* Observer status
* Performing under supervision
* Independent
* Study groups for sensory motor stimulation (5 minutes) + pacifier (2 minutes) Intervention group (Group I): by mothers
1. T1: Nurses performed all steps while mother observer status
2. T2: Nurses performed all steps in front of the mother and a pacifier was offered by the mother
3. D1: Mother performed all steps and oral milk was offered by the nurse while the mother observed.
4. D2: Mother performed all steps and offering oral milk under nurse supervision
5. D3: Mother performed all steps independently perioral sensory motor stimulation: Step 1 - 6 over 5 minutes
<!-- -->
1. With the help of the index finger, on the external surface of the cheek, make a circle starting from the angle of the mouth towards the ear then back 7x each cheek
2. While holding both sides of the cheek with help of the thumb and index finger repeat step 1 7x each cheek
3. Move index finger from one corner to opposite one over both lips separately 7x each lip
4. Gentle massage and compress the gums from center to back of mouth 7x each half of the gum
5. Move the finger from front to back on the hard palate while applying gentle pressure 7x
6. Displace the center of the tongue with gentle pressure 7x
7. Offer pacifier at the end 2 minutes Note: 7x means 7 times
|
Control Group (Group 2)
n=48 Participants
All steps were the same as the intervention group and were performed by staff nurses perioral sensory motor stimulation: Step 1 - 6 over 5 minutes
1 With the help of the index finger, on the external surface of the cheek, make a circle starting from the angle of the mouth towards the ear then back 7x each cheek 2 While holding both sides of the cheek with help of the thumb and index finger repeat step 1 7x each cheek 3 Move index finger from one corner to opposite one over both lips separately 7x each lip 4 Gentle massage and compress the gums from center to back of mouth 7x each half of the gum 5 Move the finger from front to back on the hard palate while applying gentle pressure 7x 6 Displace the center of the tongue with gentle pressure 7x 7 Offer pacifier at the end 2 minutes Note: 7x means 7 times
|
Total
n=97 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29 years
n=49 Participants
|
30 years
n=48 Participants
|
29.5 years
n=97 Participants
|
|
Sex/Gender, Customized
|
49 Participants
n=49 Participants
|
48 Participants
n=48 Participants
|
97 Participants
n=97 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Maternal education
Uneducated
|
2 Participants
n=49 Participants
|
2 Participants
n=48 Participants
|
4 Participants
n=97 Participants
|
|
Maternal education
Primary
|
11 Participants
n=49 Participants
|
10 Participants
n=48 Participants
|
21 Participants
n=97 Participants
|
|
Maternal education
Secondary
|
15 Participants
n=49 Participants
|
20 Participants
n=48 Participants
|
35 Participants
n=97 Participants
|
|
Maternal education
Higher
|
21 Participants
n=49 Participants
|
16 Participants
n=48 Participants
|
37 Participants
n=97 Participants
|
|
mothers with previous preterm neonates
|
42 Participants
n=49 Participants
|
38 Participants
n=48 Participants
|
80 Participants
n=97 Participants
|
|
Maternal Job status
home maker
|
29 Participants
n=49 Participants
|
31 Participants
n=48 Participants
|
60 Participants
n=97 Participants
|
|
Maternal Job status
job doing
|
20 Participants
n=49 Participants
|
17 Participants
n=48 Participants
|
37 Participants
n=97 Participants
|
|
hypertensive disorder of pregnancy
|
29 Participants
n=49 Participants
|
32 Participants
n=48 Participants
|
61 Participants
n=97 Participants
|
|
Gestational diabetes mellitus
|
17 Participants
n=49 Participants
|
17 Participants
n=48 Participants
|
34 Participants
n=97 Participants
|
|
anemia of pregnancy
|
25 Participants
n=49 Participants
|
21 Participants
n=48 Participants
|
46 Participants
n=97 Participants
|
|
Gravidity
Primigravida (PG)
|
20 Participants
n=49 Participants
|
26 Participants
n=48 Participants
|
46 Participants
n=97 Participants
|
|
Gravidity
2 - 3
|
22 Participants
n=49 Participants
|
15 Participants
n=48 Participants
|
37 Participants
n=97 Participants
|
|
Gravidity
4 or more
|
7 Participants
n=49 Participants
|
7 Participants
n=48 Participants
|
14 Participants
n=97 Participants
|
|
neonatal gender (male)
|
27 Participants
n=49 Participants
|
22 Participants
n=48 Participants
|
49 Participants
n=97 Participants
|
|
Gestation age at delivery
|
30 weeks
n=49 Participants
|
31 weeks
n=48 Participants
|
30.5 weeks
n=97 Participants
|
|
Mode of delivery (SVD)
|
26 Participants
n=49 Participants
|
29 Participants
n=48 Participants
|
55 Participants
n=97 Participants
|
|
Birth weight
|
1.29 Kg
n=49 Participants
|
1.34 Kg
n=48 Participants
|
1.31 Kg
n=97 Participants
|
|
Weight for gestational age
Appropriate for gestation age (AGA)
|
27 Participants
n=49 Participants
|
30 Participants
n=48 Participants
|
57 Participants
n=97 Participants
|
|
Weight for gestational age
Small for gestation age (SGA)
|
16 Participants
n=49 Participants
|
15 Participants
n=48 Participants
|
31 Participants
n=97 Participants
|
|
Weight for gestational age
Large for gestation age (LGA)
|
6 Participants
n=49 Participants
|
3 Participants
n=48 Participants
|
9 Participants
n=97 Participants
|
|
Place of birth (Inborn)
|
30 Participants
n=49 Participants
|
33 Participants
n=48 Participants
|
63 Participants
n=97 Participants
|
|
Required Invasive mechanical ventilation (IMV)
|
26 Participants
n=49 Participants
|
30 Participants
n=48 Participants
|
56 Participants
n=97 Participants
|
|
Duration of IMV
|
1 days
n=26 Participants • the number of neonates receiving IMV
|
2 days
n=30 Participants • the number of neonates receiving IMV
|
1.5 days
n=56 Participants • the number of neonates receiving IMV
|
|
Required non invasive ventilation (NIV)
|
45 Participants
n=49 Participants
|
48 Participants
n=48 Participants
|
93 Participants
n=97 Participants
|
|
Duration of non invasive ventilation (NIV)
|
3 days
n=45 Participants • Only those neonates who received non invasive ventilation (NIV)
|
4 days
n=48 Participants • Only those neonates who received non invasive ventilation (NIV)
|
3.5 days
n=93 Participants • Only those neonates who received non invasive ventilation (NIV)
|
|
Required low flow nasal cannula therapy (LFNC)
|
47 Participants
n=49 Participants
|
43 Participants
n=48 Participants
|
90 Participants
n=97 Participants
|
|
Duration of LFNC
|
4 days
n=47 Participants • Only those neonates were analysed who required LFNC
|
3.5 days
n=43 Participants • Only those neonates were analysed who required LFNC
|
3.75 days
n=90 Participants • Only those neonates were analysed who required LFNC
|
|
Apnea
|
18 Participants
n=49 Participants
|
20 Participants
n=48 Participants
|
38 Participants
n=97 Participants
|
|
Respiratory distress syndrome (RDS)
|
25 Participants
n=49 Participants
|
25 Participants
n=48 Participants
|
50 Participants
n=97 Participants
|
|
Caffeine
|
28 Participants
n=49 Participants
|
28 Participants
n=48 Participants
|
56 Participants
n=97 Participants
|
|
Hemodynamically significant patent ductus arteriosus (HsPDA)
|
17 Participants
n=49 Participants
|
20 Participants
n=48 Participants
|
37 Participants
n=97 Participants
|
|
Necrotizing enterocolitis (NEC)
|
9 Participants
n=49 Participants
|
12 Participants
n=48 Participants
|
21 Participants
n=97 Participants
|
|
Feeding intolerence
|
20 Participants
n=49 Participants
|
25 Participants
n=48 Participants
|
45 Participants
n=97 Participants
|
|
Sepsis
|
43 Participants
n=49 Participants
|
41 Participants
n=48 Participants
|
84 Participants
n=97 Participants
|
|
Seizures
|
7 Participants
n=49 Participants
|
5 Participants
n=48 Participants
|
12 Participants
n=97 Participants
|
|
Post menstural age (PMA) at enrollment
|
32 weeks
n=49 Participants
|
32 weeks
n=48 Participants
|
32 weeks
n=97 Participants
|
|
Chronological age (ChA) at enrollment
|
13 days
n=49 Participants
|
9 days
n=48 Participants
|
11 days
n=97 Participants
|
|
Time to full gavage feed
|
7 days
n=49 Participants
|
7 days
n=48 Participants
|
7 days
n=97 Participants
|
|
Discharge weight
|
1.48 Kg
n=49 Participants
|
1.48 Kg
n=48 Participants
|
1.48 Kg
n=97 Participants
|
|
Weight at enrollment
|
1.35 Kg
n=49 Participants
|
1.35 Kg
n=48 Participants
|
1.35 Kg
n=97 Participants
|
|
Duration of stay in NICU
|
21 days
n=49 Participants
|
30 days
n=48 Participants
|
25.5 days
n=97 Participants
|
PRIMARY outcome
Timeframe: Expected time of oral feed establishmentTime interval between commencement of perioral sensory stimulation on D1 to establishment of full oral feed in both groups. It was done daily till 14th day of perioral sensory motor stimulation. Transition time to full oral feeding was the day at which baby was able to take oral feed of volume of 120-140ml/kg/day.
Outcome measures
| Measure |
Intervention Group (Group 1)
n=49 Participants
* Maternal involvement was done in three stages for the intervention group as
o Observer status
* Performing under supervision
* Independent
* Study groups for sensory motor stimulation (5 minutes) + pacifier (2 minutes)
Intervention group (Group I): by mothers
1. T1: Nurses performed all steps while mother observer status
2. T2: Nurses performed all steps in front of the mother and a pacifier was offered by the mother
3. D1: Mother performed all steps and oral milk was offered by the nurse while the mother observed.
4. D2: Mother performed all steps and offering oral milk under nurse supervision
5. D3: Mother performed all steps independently
perioral sensory motor stimulation: Step 1 - 6 over 5 minutes
1 With the help of the index finger, on the external surface of the cheek, make a circle starting from the angle of the mouth towards the ear then back 7x each cheek
2 While holding both sides of the cheek with help of the thumb and index finger repeat step 1 7x each cheek
3 Move index finger from one corner to opposite one over both lips separately 7x each lip
4 Gentle massage and compress the gums from center to back of mouth 7x each half of the gum
5 Move the finger from front to back on the hard palate while applying gentle pressure 7x
6 Displace the center of the tongue with gentle pressure 7x
7 Offer pacifier at the end 2 minutes
Note: 7x means 7 times
|
Control Group (Group 2)
n=48 Participants
All steps were the same as the intervention group and were performed by staff nurses
perioral sensory motor stimulation: Step 1 - 6 over 5 minutes
1 With the help of the index finger, on the external surface of the cheek, make a circle starting from the angle of the mouth towards the ear then back 7x each cheek
2 While holding both sides of the cheek with help of the thumb and index finger repeat step 1 7x each cheek
3 Move index finger from one corner to opposite one over both lips separately 7x each lip
4 Gentle massage and compress the gums from center to back of mouth 7x each half of the gum
5 Move the finger from front to back on the hard palate while applying gentle pressure 7x
6 Displace the center of the tongue with gentle pressure 7x
7 Offer pacifier at the end 2 minutes
Note: 7x means 7 times
|
|---|---|---|
|
Transition Time to Full Oral Feeding
|
10 days
Interval 7.0 to 13.0
|
9 days
Interval 7.0 to 13.0
|
PRIMARY outcome
Timeframe: For record purpose in this study results, efficacy level was noted as L4 on the following days D1, D2, D3, D5, D7 and D14Population: neonates were assessed for efficacy of level 4 (L4) on D1, D2,D3,D5,D7 and D14
According to this efficiency in oral feed establishment in terms of amount and time is determined for the intervention group vs the control group. It can be classified into four levels depending upon the level of maturity in ascending order as follows: * Level 1: PRO \< 30% and RT \< 1.5 ml/min * Level 2: PRO \< 30% and RT ≥ 1.5 ml/min * Level 3: PRO ≥ 30% and RT \< 1.5 ml/min * Level 4: PRO ≥ 30% and RT ≥ 1.5 ml/min For all neonates, efficacy was measured at 11.00 am and 5.00 pm following sensory motor stimulation for both groups till achievement of full oral feed.
Outcome measures
| Measure |
Intervention Group (Group 1)
n=48 Participants
* Maternal involvement was done in three stages for the intervention group as
o Observer status
* Performing under supervision
* Independent
* Study groups for sensory motor stimulation (5 minutes) + pacifier (2 minutes)
Intervention group (Group I): by mothers
1. T1: Nurses performed all steps while mother observer status
2. T2: Nurses performed all steps in front of the mother and a pacifier was offered by the mother
3. D1: Mother performed all steps and oral milk was offered by the nurse while the mother observed.
4. D2: Mother performed all steps and offering oral milk under nurse supervision
5. D3: Mother performed all steps independently
perioral sensory motor stimulation: Step 1 - 6 over 5 minutes
1 With the help of the index finger, on the external surface of the cheek, make a circle starting from the angle of the mouth towards the ear then back 7x each cheek
2 While holding both sides of the cheek with help of the thumb and index finger repeat step 1 7x each cheek
3 Move index finger from one corner to opposite one over both lips separately 7x each lip
4 Gentle massage and compress the gums from center to back of mouth 7x each half of the gum
5 Move the finger from front to back on the hard palate while applying gentle pressure 7x
6 Displace the center of the tongue with gentle pressure 7x
7 Offer pacifier at the end 2 minutes
Note: 7x means 7 times
|
Control Group (Group 2)
n=49 Participants
All steps were the same as the intervention group and were performed by staff nurses
perioral sensory motor stimulation: Step 1 - 6 over 5 minutes
1 With the help of the index finger, on the external surface of the cheek, make a circle starting from the angle of the mouth towards the ear then back 7x each cheek
2 While holding both sides of the cheek with help of the thumb and index finger repeat step 1 7x each cheek
3 Move index finger from one corner to opposite one over both lips separately 7x each lip
4 Gentle massage and compress the gums from center to back of mouth 7x each half of the gum
5 Move the finger from front to back on the hard palate while applying gentle pressure 7x
6 Displace the center of the tongue with gentle pressure 7x
7 Offer pacifier at the end 2 minutes
Note: 7x means 7 times
|
|---|---|---|
|
Improvement (Change) in Efficiency in Oral Feed Establishment
L4 efficacy by D1-3
|
0 Participants
|
0 Participants
|
|
Improvement (Change) in Efficiency in Oral Feed Establishment
L4 efficacy by D5
|
9 Participants
|
12 Participants
|
|
Improvement (Change) in Efficiency in Oral Feed Establishment
L4 efficacy by D7
|
15 Participants
|
16 Participants
|
|
Improvement (Change) in Efficiency in Oral Feed Establishment
L4 efficacy by D14
|
36 Participants
|
35 Participants
|
PRIMARY outcome
Timeframe: Adverse events were noted on D1, D2,D3,D5,D7 and D14Population: All neonates were monitored for adverse outcome. This monitoring was done as non-life threatening adverse events including cough, tachycardia HR 180-200/min, bradycardia HR120 - 100/min, , tachypnea RR 60 - 70/min while maintaining SpO2 of \>90% at room air
monitor for any adverse events like cough, breath holding, chocking, aspiration, tachycardia, and or bradycardia with 1. stimulation 2. feed Adverse outcome monitoring as non-life threatening adverse events including cough, tachycardia HR 180-200/min, bradycardia HR120 - 100/min, , tachypnea RR 60 - 70/min while maintaining SpO2 of \>90% at room air
Outcome measures
| Measure |
Intervention Group (Group 1)
n=48 Participants
* Maternal involvement was done in three stages for the intervention group as
o Observer status
* Performing under supervision
* Independent
* Study groups for sensory motor stimulation (5 minutes) + pacifier (2 minutes)
Intervention group (Group I): by mothers
1. T1: Nurses performed all steps while mother observer status
2. T2: Nurses performed all steps in front of the mother and a pacifier was offered by the mother
3. D1: Mother performed all steps and oral milk was offered by the nurse while the mother observed.
4. D2: Mother performed all steps and offering oral milk under nurse supervision
5. D3: Mother performed all steps independently
perioral sensory motor stimulation: Step 1 - 6 over 5 minutes
1 With the help of the index finger, on the external surface of the cheek, make a circle starting from the angle of the mouth towards the ear then back 7x each cheek
2 While holding both sides of the cheek with help of the thumb and index finger repeat step 1 7x each cheek
3 Move index finger from one corner to opposite one over both lips separately 7x each lip
4 Gentle massage and compress the gums from center to back of mouth 7x each half of the gum
5 Move the finger from front to back on the hard palate while applying gentle pressure 7x
6 Displace the center of the tongue with gentle pressure 7x
7 Offer pacifier at the end 2 minutes
Note: 7x means 7 times
|
Control Group (Group 2)
n=49 Participants
All steps were the same as the intervention group and were performed by staff nurses
perioral sensory motor stimulation: Step 1 - 6 over 5 minutes
1 With the help of the index finger, on the external surface of the cheek, make a circle starting from the angle of the mouth towards the ear then back 7x each cheek
2 While holding both sides of the cheek with help of the thumb and index finger repeat step 1 7x each cheek
3 Move index finger from one corner to opposite one over both lips separately 7x each lip
4 Gentle massage and compress the gums from center to back of mouth 7x each half of the gum
5 Move the finger from front to back on the hard palate while applying gentle pressure 7x
6 Displace the center of the tongue with gentle pressure 7x
7 Offer pacifier at the end 2 minutes
Note: 7x means 7 times
|
|---|---|---|
|
•Adverse Outcome Monitoring
Adverse events D1
|
31 Participants
|
36 Participants
|
|
•Adverse Outcome Monitoring
Adverse events D2
|
14 Participants
|
14 Participants
|
|
•Adverse Outcome Monitoring
Adverse events D3
|
12 Participants
|
12 Participants
|
|
•Adverse Outcome Monitoring
Averse events D5
|
0 Participants
|
2 Participants
|
|
•Adverse Outcome Monitoring
Adverse events D7 & 14
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Adverse events were noted on D1, D2,D3,D5,D7 and D14Population: All neonates were monitored for adverse outcome. This monitoring was done as non-life threatening adverse events including cough, tachycardia HR 180-200/min, bradycardia HR120 - 100/min, , tachypnea RR 60 - 70/min while maintaining SpO2 of \>90% at room air
monitor for any adverse events like cough, breath holding, chocking, aspiration, tachycardia, and or bradycardia with 1. stimulation 2. feed Adverse outcome monitoring as non-life threatening adverse events including cough, tachycardia HR 180-200/min, bradycardia HR120 - 100/min, , tachypnea RR 60 - 70/min while maintaining SpO2 of \>90% at room air
Outcome measures
| Measure |
Intervention Group (Group 1)
n=48 Participants
* Maternal involvement was done in three stages for the intervention group as
o Observer status
* Performing under supervision
* Independent
* Study groups for sensory motor stimulation (5 minutes) + pacifier (2 minutes)
Intervention group (Group I): by mothers
1. T1: Nurses performed all steps while mother observer status
2. T2: Nurses performed all steps in front of the mother and a pacifier was offered by the mother
3. D1: Mother performed all steps and oral milk was offered by the nurse while the mother observed.
4. D2: Mother performed all steps and offering oral milk under nurse supervision
5. D3: Mother performed all steps independently
perioral sensory motor stimulation: Step 1 - 6 over 5 minutes
1 With the help of the index finger, on the external surface of the cheek, make a circle starting from the angle of the mouth towards the ear then back 7x each cheek
2 While holding both sides of the cheek with help of the thumb and index finger repeat step 1 7x each cheek
3 Move index finger from one corner to opposite one over both lips separately 7x each lip
4 Gentle massage and compress the gums from center to back of mouth 7x each half of the gum
5 Move the finger from front to back on the hard palate while applying gentle pressure 7x
6 Displace the center of the tongue with gentle pressure 7x
7 Offer pacifier at the end 2 minutes
Note: 7x means 7 times
|
Control Group (Group 2)
n=49 Participants
All steps were the same as the intervention group and were performed by staff nurses
perioral sensory motor stimulation: Step 1 - 6 over 5 minutes
1 With the help of the index finger, on the external surface of the cheek, make a circle starting from the angle of the mouth towards the ear then back 7x each cheek
2 While holding both sides of the cheek with help of the thumb and index finger repeat step 1 7x each cheek
3 Move index finger from one corner to opposite one over both lips separately 7x each lip
4 Gentle massage and compress the gums from center to back of mouth 7x each half of the gum
5 Move the finger from front to back on the hard palate while applying gentle pressure 7x
6 Displace the center of the tongue with gentle pressure 7x
7 Offer pacifier at the end 2 minutes
Note: 7x means 7 times
|
|---|---|---|
|
•Adverse Events Monitoring
Adverse events D1
|
31 Participants
|
36 Participants
|
|
•Adverse Events Monitoring
Adverse events D2
|
14 Participants
|
14 Participants
|
|
•Adverse Events Monitoring
Adverse events D3
|
12 Participants
|
12 Participants
|
|
•Adverse Events Monitoring
Averse events D5
|
0 Participants
|
2 Participants
|
|
•Adverse Events Monitoring
Adverse events D7 & 14
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: It was noted on D1, D2, D3, D5, D7 and D14It is the measure of how much feed has been taken orally out of total feed prescribed for each feeding
Outcome measures
| Measure |
Intervention Group (Group 1)
n=48 Participants
* Maternal involvement was done in three stages for the intervention group as
o Observer status
* Performing under supervision
* Independent
* Study groups for sensory motor stimulation (5 minutes) + pacifier (2 minutes)
Intervention group (Group I): by mothers
1. T1: Nurses performed all steps while mother observer status
2. T2: Nurses performed all steps in front of the mother and a pacifier was offered by the mother
3. D1: Mother performed all steps and oral milk was offered by the nurse while the mother observed.
4. D2: Mother performed all steps and offering oral milk under nurse supervision
5. D3: Mother performed all steps independently
perioral sensory motor stimulation: Step 1 - 6 over 5 minutes
1 With the help of the index finger, on the external surface of the cheek, make a circle starting from the angle of the mouth towards the ear then back 7x each cheek
2 While holding both sides of the cheek with help of the thumb and index finger repeat step 1 7x each cheek
3 Move index finger from one corner to opposite one over both lips separately 7x each lip
4 Gentle massage and compress the gums from center to back of mouth 7x each half of the gum
5 Move the finger from front to back on the hard palate while applying gentle pressure 7x
6 Displace the center of the tongue with gentle pressure 7x
7 Offer pacifier at the end 2 minutes
Note: 7x means 7 times
|
Control Group (Group 2)
n=49 Participants
All steps were the same as the intervention group and were performed by staff nurses
perioral sensory motor stimulation: Step 1 - 6 over 5 minutes
1 With the help of the index finger, on the external surface of the cheek, make a circle starting from the angle of the mouth towards the ear then back 7x each cheek
2 While holding both sides of the cheek with help of the thumb and index finger repeat step 1 7x each cheek
3 Move index finger from one corner to opposite one over both lips separately 7x each lip
4 Gentle massage and compress the gums from center to back of mouth 7x each half of the gum
5 Move the finger from front to back on the hard palate while applying gentle pressure 7x
6 Displace the center of the tongue with gentle pressure 7x
7 Offer pacifier at the end 2 minutes
Note: 7x means 7 times
|
|---|---|---|
|
• Total Volume Taken During Each Feeding
Oral feed volume/feed on D7
|
7.5 ml
Interval 7.0 to 20.0
|
9 ml
Interval 7.0 to 18.0
|
|
• Total Volume Taken During Each Feeding
Oral feed volume/feed on D14
|
15.5 ml
Interval 14.0 to 22.0
|
15.5 ml
Interval 13.0 to 20.5
|
|
• Total Volume Taken During Each Feeding
Oral feed volume/feed on D1
|
2 ml
Interval 2.0 to 7.0
|
2 ml
Interval 2.0 to 7.0
|
|
• Total Volume Taken During Each Feeding
Oral feed volume/feed on D2
|
3 ml
Interval 2.0 to 7.0
|
5 ml
Interval 2.0 to 9.0
|
|
• Total Volume Taken During Each Feeding
Oral feed volume/feed on D3
|
4 ml
Interval 3.0 to 10.0
|
7 ml
Interval 3.0 to 11.0
|
|
• Total Volume Taken During Each Feeding
Oral feed volume/feed on D5
|
6.5 ml
Interval 5.0 to 15.0
|
8 ml
Interval 5.0 to 15.0
|
SECONDARY outcome
Timeframe: Volume taken during the first 5 min of feeding (ml) VT5 was measured on D1, D2, D3, D5, D7 and D14during each feed taken orally by neonate VT5 is the amount of feed was taken by neonate during first 5 minutes
Outcome measures
| Measure |
Intervention Group (Group 1)
n=48 Participants
* Maternal involvement was done in three stages for the intervention group as
o Observer status
* Performing under supervision
* Independent
* Study groups for sensory motor stimulation (5 minutes) + pacifier (2 minutes)
Intervention group (Group I): by mothers
1. T1: Nurses performed all steps while mother observer status
2. T2: Nurses performed all steps in front of the mother and a pacifier was offered by the mother
3. D1: Mother performed all steps and oral milk was offered by the nurse while the mother observed.
4. D2: Mother performed all steps and offering oral milk under nurse supervision
5. D3: Mother performed all steps independently
perioral sensory motor stimulation: Step 1 - 6 over 5 minutes
1 With the help of the index finger, on the external surface of the cheek, make a circle starting from the angle of the mouth towards the ear then back 7x each cheek
2 While holding both sides of the cheek with help of the thumb and index finger repeat step 1 7x each cheek
3 Move index finger from one corner to opposite one over both lips separately 7x each lip
4 Gentle massage and compress the gums from center to back of mouth 7x each half of the gum
5 Move the finger from front to back on the hard palate while applying gentle pressure 7x
6 Displace the center of the tongue with gentle pressure 7x
7 Offer pacifier at the end 2 minutes
Note: 7x means 7 times
|
Control Group (Group 2)
n=49 Participants
All steps were the same as the intervention group and were performed by staff nurses
perioral sensory motor stimulation: Step 1 - 6 over 5 minutes
1 With the help of the index finger, on the external surface of the cheek, make a circle starting from the angle of the mouth towards the ear then back 7x each cheek
2 While holding both sides of the cheek with help of the thumb and index finger repeat step 1 7x each cheek
3 Move index finger from one corner to opposite one over both lips separately 7x each lip
4 Gentle massage and compress the gums from center to back of mouth 7x each half of the gum
5 Move the finger from front to back on the hard palate while applying gentle pressure 7x
6 Displace the center of the tongue with gentle pressure 7x
7 Offer pacifier at the end 2 minutes
Note: 7x means 7 times
|
|---|---|---|
|
• Volume Taken During the First 5 Min of Feeding (ml) VT5
VT5 on D1
|
2 ml
Interval 1.25 to 4.0
|
2 ml
Interval 1.0 to 4.5
|
|
• Volume Taken During the First 5 Min of Feeding (ml) VT5
VT5 on D2
|
3 ml
Interval 2.0 to 5.0
|
3 ml
Interval 2.0 to 6.0
|
|
• Volume Taken During the First 5 Min of Feeding (ml) VT5
VT5 on D3
|
3 ml
Interval 2.0 to 7.0
|
3 ml
Interval 2.0 to 7.0
|
|
• Volume Taken During the First 5 Min of Feeding (ml) VT5
VT5 on D5
|
5 ml
Interval 4.0 to 8.0
|
5 ml
Interval 4.0 to 9.0
|
|
• Volume Taken During the First 5 Min of Feeding (ml) VT5
VT5 on D7
|
7 ml
Interval 6.0 to 10.0
|
7 ml
Interval 5.5 to 11.0
|
|
• Volume Taken During the First 5 Min of Feeding (ml) VT5
VT5 on D14
|
10 ml
Interval 9.0 to 10.0
|
10 ml
Interval 9.0 to 12.5
|
SECONDARY outcome
Timeframe: RT was measured on D1, D2, D3, D5, D7 and D14RT is the time taken by neonate to finish oral feed
Outcome measures
| Measure |
Intervention Group (Group 1)
n=48 Participants
* Maternal involvement was done in three stages for the intervention group as
o Observer status
* Performing under supervision
* Independent
* Study groups for sensory motor stimulation (5 minutes) + pacifier (2 minutes)
Intervention group (Group I): by mothers
1. T1: Nurses performed all steps while mother observer status
2. T2: Nurses performed all steps in front of the mother and a pacifier was offered by the mother
3. D1: Mother performed all steps and oral milk was offered by the nurse while the mother observed.
4. D2: Mother performed all steps and offering oral milk under nurse supervision
5. D3: Mother performed all steps independently
perioral sensory motor stimulation: Step 1 - 6 over 5 minutes
1 With the help of the index finger, on the external surface of the cheek, make a circle starting from the angle of the mouth towards the ear then back 7x each cheek
2 While holding both sides of the cheek with help of the thumb and index finger repeat step 1 7x each cheek
3 Move index finger from one corner to opposite one over both lips separately 7x each lip
4 Gentle massage and compress the gums from center to back of mouth 7x each half of the gum
5 Move the finger from front to back on the hard palate while applying gentle pressure 7x
6 Displace the center of the tongue with gentle pressure 7x
7 Offer pacifier at the end 2 minutes
Note: 7x means 7 times
|
Control Group (Group 2)
n=49 Participants
All steps were the same as the intervention group and were performed by staff nurses
perioral sensory motor stimulation: Step 1 - 6 over 5 minutes
1 With the help of the index finger, on the external surface of the cheek, make a circle starting from the angle of the mouth towards the ear then back 7x each cheek
2 While holding both sides of the cheek with help of the thumb and index finger repeat step 1 7x each cheek
3 Move index finger from one corner to opposite one over both lips separately 7x each lip
4 Gentle massage and compress the gums from center to back of mouth 7x each half of the gum
5 Move the finger from front to back on the hard palate while applying gentle pressure 7x
6 Displace the center of the tongue with gentle pressure 7x
7 Offer pacifier at the end 2 minutes
Note: 7x means 7 times
|
|---|---|---|
|
•Rate of Transfer (RT) ml/Min
RT on D7
|
1.0 ml/min
Interval 0.67 to 1.7
|
1.0 ml/min
Interval 0.68 to 1.6
|
|
•Rate of Transfer (RT) ml/Min
RT on D1
|
0.42 ml/min
Interval 0.28 to 0.7
|
0.42 ml/min
Interval 0.24 to 0.85
|
|
•Rate of Transfer (RT) ml/Min
RT on D2
|
0.71 ml/min
Interval 0.7 to 1.0
|
0.70 ml/min
Interval 0.59 to 1.0
|
|
•Rate of Transfer (RT) ml/Min
RT on D3
|
0.70 ml/min
Interval 0.4 to 1.0
|
0.70 ml/min
Interval 0.4 to 1.0
|
|
•Rate of Transfer (RT) ml/Min
RT on D5
|
0.90 ml/min
Interval 0.5 to 1.2
|
0.83 ml/min
Interval 0.5 to 1.45
|
|
•Rate of Transfer (RT) ml/Min
RT on D14
|
1.6 ml/min
Interval 1.1 to 2.1
|
1.6 ml/min
Interval 1.1 to 2.1
|
SECONDARY outcome
Timeframe: OT was measured on D1, D2, D3, D5, D7 and D14trend towards oral feed establishment and is measured as overall transfer of milk yo oral out of total amount prescribed
Outcome measures
| Measure |
Intervention Group (Group 1)
n=48 Participants
* Maternal involvement was done in three stages for the intervention group as
o Observer status
* Performing under supervision
* Independent
* Study groups for sensory motor stimulation (5 minutes) + pacifier (2 minutes)
Intervention group (Group I): by mothers
1. T1: Nurses performed all steps while mother observer status
2. T2: Nurses performed all steps in front of the mother and a pacifier was offered by the mother
3. D1: Mother performed all steps and oral milk was offered by the nurse while the mother observed.
4. D2: Mother performed all steps and offering oral milk under nurse supervision
5. D3: Mother performed all steps independently
perioral sensory motor stimulation: Step 1 - 6 over 5 minutes
1 With the help of the index finger, on the external surface of the cheek, make a circle starting from the angle of the mouth towards the ear then back 7x each cheek
2 While holding both sides of the cheek with help of the thumb and index finger repeat step 1 7x each cheek
3 Move index finger from one corner to opposite one over both lips separately 7x each lip
4 Gentle massage and compress the gums from center to back of mouth 7x each half of the gum
5 Move the finger from front to back on the hard palate while applying gentle pressure 7x
6 Displace the center of the tongue with gentle pressure 7x
7 Offer pacifier at the end 2 minutes
Note: 7x means 7 times
|
Control Group (Group 2)
n=49 Participants
All steps were the same as the intervention group and were performed by staff nurses
perioral sensory motor stimulation: Step 1 - 6 over 5 minutes
1 With the help of the index finger, on the external surface of the cheek, make a circle starting from the angle of the mouth towards the ear then back 7x each cheek
2 While holding both sides of the cheek with help of the thumb and index finger repeat step 1 7x each cheek
3 Move index finger from one corner to opposite one over both lips separately 7x each lip
4 Gentle massage and compress the gums from center to back of mouth 7x each half of the gum
5 Move the finger from front to back on the hard palate while applying gentle pressure 7x
6 Displace the center of the tongue with gentle pressure 7x
7 Offer pacifier at the end 2 minutes
Note: 7x means 7 times
|
|---|---|---|
|
• Overall Transfer (OT Percent) Volume Taken/Total Volume Prescribed
OT on D1
|
21 percentage of volume taken/total volume
Interval 15.3 to 36.0
|
21 percentage of volume taken/total volume
Interval 15.0 to 36.0
|
|
• Overall Transfer (OT Percent) Volume Taken/Total Volume Prescribed
OT on D2
|
35.7 percentage of volume taken/total volume
Interval 15.0 to 36.0
|
36 percentage of volume taken/total volume
Interval 15.0 to 44.0
|
|
• Overall Transfer (OT Percent) Volume Taken/Total Volume Prescribed
OT on D3
|
43.8 percentage of volume taken/total volume
Interval 21.0 to 50.0
|
43.8 percentage of volume taken/total volume
Interval 21.0 to 55.5
|
|
• Overall Transfer (OT Percent) Volume Taken/Total Volume Prescribed
OT on D5
|
48 percentage of volume taken/total volume
Interval 33.0 to 65.0
|
48 percentage of volume taken/total volume
Interval 33.0 to 65.0
|
|
• Overall Transfer (OT Percent) Volume Taken/Total Volume Prescribed
OT on D7
|
56 percentage of volume taken/total volume
Interval 46.0 to 100.0
|
60 percentage of volume taken/total volume
Interval 46.0 to 73.5
|
|
• Overall Transfer (OT Percent) Volume Taken/Total Volume Prescribed
OT on D14
|
95.5 percentage of volume taken/total volume
Interval 87.9 to 100.0
|
91 percentage of volume taken/total volume
Interval 87.0 to 100.0
|
SECONDARY outcome
Timeframe: PRO % was measured on D1, D2, D3, D5, D7 and D14how much amount of milk is taken during first 5 minutes while administering oral feeding
Outcome measures
| Measure |
Intervention Group (Group 1)
n=48 Participants
* Maternal involvement was done in three stages for the intervention group as
o Observer status
* Performing under supervision
* Independent
* Study groups for sensory motor stimulation (5 minutes) + pacifier (2 minutes)
Intervention group (Group I): by mothers
1. T1: Nurses performed all steps while mother observer status
2. T2: Nurses performed all steps in front of the mother and a pacifier was offered by the mother
3. D1: Mother performed all steps and oral milk was offered by the nurse while the mother observed.
4. D2: Mother performed all steps and offering oral milk under nurse supervision
5. D3: Mother performed all steps independently
perioral sensory motor stimulation: Step 1 - 6 over 5 minutes
1 With the help of the index finger, on the external surface of the cheek, make a circle starting from the angle of the mouth towards the ear then back 7x each cheek
2 While holding both sides of the cheek with help of the thumb and index finger repeat step 1 7x each cheek
3 Move index finger from one corner to opposite one over both lips separately 7x each lip
4 Gentle massage and compress the gums from center to back of mouth 7x each half of the gum
5 Move the finger from front to back on the hard palate while applying gentle pressure 7x
6 Displace the center of the tongue with gentle pressure 7x
7 Offer pacifier at the end 2 minutes
Note: 7x means 7 times
|
Control Group (Group 2)
n=49 Participants
All steps were the same as the intervention group and were performed by staff nurses
perioral sensory motor stimulation: Step 1 - 6 over 5 minutes
1 With the help of the index finger, on the external surface of the cheek, make a circle starting from the angle of the mouth towards the ear then back 7x each cheek
2 While holding both sides of the cheek with help of the thumb and index finger repeat step 1 7x each cheek
3 Move index finger from one corner to opposite one over both lips separately 7x each lip
4 Gentle massage and compress the gums from center to back of mouth 7x each half of the gum
5 Move the finger from front to back on the hard palate while applying gentle pressure 7x
6 Displace the center of the tongue with gentle pressure 7x
7 Offer pacifier at the end 2 minutes
Note: 7x means 7 times
|
|---|---|---|
|
• Proficiency(PRO Percent) Volume Taken During the First 5 Min/Total Volume Prescribed
PRO on D1
|
16 percentage of volume taken during the fi
Interval 9.2 to 21.0
|
16 percentage of volume taken during the fi
Interval 7.8 to 24.0
|
|
• Proficiency(PRO Percent) Volume Taken During the First 5 Min/Total Volume Prescribed
PRO on D2
|
21 percentage of volume taken during the fi
Interval 15.0 to 27.0
|
21.6 percentage of volume taken during the fi
Interval 15.0 to 32.5
|
|
• Proficiency(PRO Percent) Volume Taken During the First 5 Min/Total Volume Prescribed
PRO on D3
|
19.5 percentage of volume taken during the fi
Interval 14.0 to 31.0
|
23 percentage of volume taken during the fi
Interval 14.0 to 37.0
|
|
• Proficiency(PRO Percent) Volume Taken During the First 5 Min/Total Volume Prescribed
PRO on D5
|
29 percentage of volume taken during the fi
Interval 24.5 to 39.0
|
30 percentage of volume taken during the fi
Interval 25.0 to 39.0
|
|
• Proficiency(PRO Percent) Volume Taken During the First 5 Min/Total Volume Prescribed
PRO on D7
|
39 percentage of volume taken during the fi
Interval 32.0 to 46.0
|
39 percentage of volume taken during the fi
Interval 33.0 to 49.5
|
|
• Proficiency(PRO Percent) Volume Taken During the First 5 Min/Total Volume Prescribed
PRO on D14
|
55.8 percentage of volume taken during the fi
Interval 46.0 to 56.0
|
56 percentage of volume taken during the fi
Interval 50.0 to 60.0
|
SECONDARY outcome
Timeframe: It was measured on D1, D2, D3, D5, D7 and D14number of neonates who are feeding well and showing coordinated pattern of suck swallow and breath (SSB)
Outcome measures
| Measure |
Intervention Group (Group 1)
n=48 Participants
* Maternal involvement was done in three stages for the intervention group as
o Observer status
* Performing under supervision
* Independent
* Study groups for sensory motor stimulation (5 minutes) + pacifier (2 minutes)
Intervention group (Group I): by mothers
1. T1: Nurses performed all steps while mother observer status
2. T2: Nurses performed all steps in front of the mother and a pacifier was offered by the mother
3. D1: Mother performed all steps and oral milk was offered by the nurse while the mother observed.
4. D2: Mother performed all steps and offering oral milk under nurse supervision
5. D3: Mother performed all steps independently
perioral sensory motor stimulation: Step 1 - 6 over 5 minutes
1 With the help of the index finger, on the external surface of the cheek, make a circle starting from the angle of the mouth towards the ear then back 7x each cheek
2 While holding both sides of the cheek with help of the thumb and index finger repeat step 1 7x each cheek
3 Move index finger from one corner to opposite one over both lips separately 7x each lip
4 Gentle massage and compress the gums from center to back of mouth 7x each half of the gum
5 Move the finger from front to back on the hard palate while applying gentle pressure 7x
6 Displace the center of the tongue with gentle pressure 7x
7 Offer pacifier at the end 2 minutes
Note: 7x means 7 times
|
Control Group (Group 2)
n=49 Participants
All steps were the same as the intervention group and were performed by staff nurses
perioral sensory motor stimulation: Step 1 - 6 over 5 minutes
1 With the help of the index finger, on the external surface of the cheek, make a circle starting from the angle of the mouth towards the ear then back 7x each cheek
2 While holding both sides of the cheek with help of the thumb and index finger repeat step 1 7x each cheek
3 Move index finger from one corner to opposite one over both lips separately 7x each lip
4 Gentle massage and compress the gums from center to back of mouth 7x each half of the gum
5 Move the finger from front to back on the hard palate while applying gentle pressure 7x
6 Displace the center of the tongue with gentle pressure 7x
7 Offer pacifier at the end 2 minutes
Note: 7x means 7 times
|
|---|---|---|
|
• Neonates Feeding With SSB Coordination
SSB on D1
|
23 Participants
|
22 Participants
|
|
• Neonates Feeding With SSB Coordination
SSB on D2
|
27 Participants
|
33 Participants
|
|
• Neonates Feeding With SSB Coordination
SSB on D3
|
32 Participants
|
33 Participants
|
|
• Neonates Feeding With SSB Coordination
SSB on D5
|
37 Participants
|
40 Participants
|
|
• Neonates Feeding With SSB Coordination
SSB on D7
|
36 Participants
|
39 Participants
|
|
• Neonates Feeding With SSB Coordination
SSB on D14
|
48 Participants
|
49 Participants
|
Adverse Events
Intervention Group (Group 1)
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Control Group (Group 2)
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intervention Group (Group 1)
n=49 participants at risk
* Maternal involvement shall be in three stages for the intervention group as
o Observer status
* Performing under supervision
* Independent
* Study groups for sensory motor stimulation (5 minutes) + pacifier (2 minutes)
Intervention group (Group I): by mothers
1. T1: Nurses performing all steps while mother observer status
2. T2: Nurses perform all steps in front of the mother and a pacifier will be offered by the mother
3. D1: Mother performs all steps and oral milk shall be offered by the nurse while the mother observes.
4. D2: Mother performing all steps and offering oral milk while the nurse is supervising
5. D3: Mother performing all steps independently
perioral sensory motor stimulation: Step 1 - 6 over 5 minutes
1 With the help of the index finger, on the external surface of the cheek, make a circle starting from the angle of the mouth towards the ear then back 7x each cheek
2 While holding both sides of the cheek with help of the thumb and index finger repeat step 1 7x each cheek
3 Move index finger from one corner to opposite one over both lips separately 7x each lip
4 Gentle massage and compress the gums from center to back of mouth 7x each half of the gum
5 Move the finger from front to back on the hard palate while applying gentle pressure 7x
6 Displace the center of the tongue with gentle pressure 7x
7 Offer pacifier at the end 2 minutes
Note: 7x means 7 times
|
Control Group (Group 2)
n=48 participants at risk
All steps will be the same as the intervention group and shall be performed by staff nurses
perioral sensory motor stimulation: Step 1 - 6 over 5 minutes
1 With the help of the index finger, on the external surface of the cheek, make a circle starting from the angle of the mouth towards the ear then back 7x each cheek
2 While holding both sides of the cheek with help of the thumb and index finger repeat step 1 7x each cheek
3 Move index finger from one corner to opposite one over both lips separately 7x each lip
4 Gentle massage and compress the gums from center to back of mouth 7x each half of the gum
5 Move the finger from front to back on the hard palate while applying gentle pressure 7x
6 Displace the center of the tongue with gentle pressure 7x
7 Offer pacifier at the end 2 minutes
Note: 7x means 7 times
|
|---|---|---|
|
Injury, poisoning and procedural complications
Non-life threatening adverse events
|
32.7%
16/49 • For every neonate adverse events were monitored from first day (D1) of perioral sensory - motor stimulation to day of full oral feed establishment expected by Day 14
Only those neonates were enrolled in study who were stable enough to tolerate the procedure of sensory motor stimulation and feeding.
|
39.6%
19/48 • For every neonate adverse events were monitored from first day (D1) of perioral sensory - motor stimulation to day of full oral feed establishment expected by Day 14
Only those neonates were enrolled in study who were stable enough to tolerate the procedure of sensory motor stimulation and feeding.
|
Additional Information
Assistant Professor Dr Rafia Gul
Fatima Memorial Hospital Shadman Lahore
Phone: 00923064620027
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place