Maternal Role in Oral Feed Establishment in Preterm Neonates
NCT ID: NCT05484726
Last Updated: 2024-12-02
Study Results
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View full resultsBasic Information
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COMPLETED
NA
130 participants
INTERVENTIONAL
2022-03-01
2023-09-06
Brief Summary
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Preterm babies who receive sensory motor stimulation from their mothers as compared to trained nurses will
1. Start taking oral feed at the same time as compared to control group
2. Take the same amount of milk at the commencement of oral feeding
3. Take milk with equal efficiency
4. Not face more adverse effects
Detailed Description
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1. Determine the effect of sensory-motor stimulation offered by the mother on the onset of oral feeding
2. Efficiency of mother-mediated stimulation techniques on oral feeding as compared to trained nurses
3. Study maternal role in the establishment of oral feed Hypothesis Preterm babies who receive sensory motor stimulation from their mothers as compared to trained nurses will
1\. Start taking oral feed at the same time frame as compared to the control group 2. Take the very same amount of milk at the commencement of oral feeding 3. Take milk with equal efficiency 4. There is no extra burden of adverse effects
Data Collection All on going and related trials for this intervention shall be registered in the ClinicalTrials.gov. Study shall be conducted after ethical approval from IRB. All participants shall be enrolled after written informed consent from mothers after approval from attending neonatologist (annexure 2). All relevant maternal and neonatal data shall be collected on a specially designed proforma (annexure 3) with following details
1. Part 1: Maternal demographic and clinical data (age, parity, educational qualification, residence, previous preterm baby, job status, diabetes, hypertensive disorders, chronic ailment, multifetal gestation
2. Part 2: Neonatal demographic data (gender, gestation age, birth weight, growth centiles, diagnosis, APGAR score, noninvasive (NIV) and invasive ventilation with duration, caffeine, days taken for establishment of gavage feeding, age, and weight at commencement of intervention, any other complication during study)
3. Part 3: Neonatal feeding physiological measurements (SpO2, respiratory rate, heart rate before and after feeding, daily weight gain, type of milk offered)
4. Part 4: Oral feeding skill (OFS) assessment adapted from the model presented by Lau and Smith (p). All parameters shall be recorded twice a day for D1, D2, and D3 separately. It includes
* Total volume prescribed (ml)
* Total volume has taken during feeding (ml)
* Volume has taken during the first 5 min of feeding (ml)
* Duration of oral feeding (min)
* Overall transfer (OT %) volume taken/total volume prescribed
* Proficiency(PRO%) volume taken during the first 5 min/total volume prescribed
* Rate of transfer (RT) ml/min
* SSB (Suck Swallow Breaths) coordination
* Adverse events (cough, fatigue)
* According to this oral feeding ability 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
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
1. Observer status
2. Performing under supervision
3. Independent
2. Intervention period: 5 days as
1. Training phase (T): T1 and T2 (for mothers by the nurse)
2. Direct feeding phase (D): F1, 2, and 3 (oral feed shall be offered to neonate)
3. Stimulation for 7 minutes and 15 minutes before feeding twice a day at 1100 and 1700 hrs.
4. Two groups
1. Intervention group (GI): by mothers
2. Control group (G II): by staff nurses
SUPPORTIVE_CARE
SINGLE
Study Groups
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Intervention group (Group 1)
* Maternal involvement shall be 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 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)
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Haemodynamically stable
* Established full Gavage feed
* No respiratory distress
* No need for respiratory support except LFNC
* Do not receive any kind of analgesics
Exclusion Criteria
* Haemodynamically unstable babies including IVH (grade III \& IV), hemodynamically significant PDA on treatment, NEC(stage III)
* Major malformations
* Cleft lip and palate
* Anemia requiring blood transfusion
30 Weeks
34 Weeks
ALL
Yes
Sponsors
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Fatima Memorial Hospital
OTHER
Responsible Party
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Rafia Gul
Assistant Professor
Principal Investigators
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Rafia Gul, FCPS (Neo)
Role: PRINCIPAL_INVESTIGATOR
Fatima Memorial Hospital
Locations
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Rafia Gul
Lahore, Shadman, Pakistan
Countries
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References
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da Rosa Pereira K, Levy DS, Procianoy RS, Silveira RC. Impact of a pre-feeding oral stimulation program on first feed attempt in preterm infants: Double-blind controlled clinical trial. PLoS One. 2020 Sep 9;15(9):e0237915. doi: 10.1371/journal.pone.0237915. eCollection 2020.
Murthy SV, Funderburk A, Abraham S, Epstein M, DiPalma J, Aghai ZH. Nasogastric Feeding Tubes May Not Contribute to Gastroesophageal Reflux in Preterm Infants. Am J Perinatol. 2018 Jun;35(7):643-647. doi: 10.1055/s-0037-1608875. Epub 2017 Nov 30.
Rogers SP, Hicks PD, Hamzo M, Veit LE, Abrams SA. Continuous feedings of fortified human milk lead to nutrient losses of fat, calcium and phosphorous. Nutrients. 2010 Mar;2(3):230-40. doi: 10.3390/nu2030240. Epub 2010 Feb 26.
Viswanathan S, Jadcherla S. Transitioning from gavage to full oral feeds in premature infants: When should we discontinue the nasogastric tube? J Perinatol. 2019 Sep;39(9):1257-1262. doi: 10.1038/s41372-019-0446-2. Epub 2019 Jul 31.
Greene Z, O'Donnell CP, Walshe M. Oral stimulation for promoting oral feeding in preterm infants. Cochrane Database Syst Rev. 2016 Sep 20;9(9):CD009720. doi: 10.1002/14651858.CD009720.pub2.
6. Maltese A, Gallai B, Marotta R, Lavano F, Lavano S, Tripi G. The synactive theory of development: the keyword for neurodevelopmental disorders. Acta Medica Mediterranea, 2017, 33: 1257-63
Song D, Jegatheesan P, Nafday S, Ahmad KA, Nedrelow J, Wearden M, Nemerofsky S, Pooley S, Thompson D, Vail D, Cornejo T, Cohen Z, Govindaswami B. Patterned frequency-modulated oral stimulation in preterm infants: A multicenter randomized controlled trial. PLoS One. 2019 Feb 28;14(2):e0212675. doi: 10.1371/journal.pone.0212675. eCollection 2019.
Bertoncelli N, Cuomo G, Cattani S, Mazzi C, Pugliese M, Coccolini E, Zagni P, Mordini B, Ferrari F. Oral feeding competences of healthy preterm infants: a review. Int J Pediatr. 2012;2012:896257. doi: 10.1155/2012/896257. Epub 2012 May 17.
Simpson C, Schanler RJ, Lau C. Early introduction of oral feeding in preterm infants. Pediatrics. 2002 Sep;110(3):517-22. doi: 10.1542/peds.110.3.517.
Lau C, Sheena HR, Shulman RJ, Schanler RJ. Oral feeding in low birth weight infants. J Pediatr. 1997 Apr;130(4):561-9. doi: 10.1016/s0022-3476(97)70240-3.
Sarin E, Maria A. Acceptability of a family-centered newborn care model among providers and receivers of care in a Public Health Setting: a qualitative study from India. BMC Health Serv Res. 2019 Mar 21;19(1):184. doi: 10.1186/s12913-019-4017-1.
13. Fonseca SA, Silveira AO, Franzoi MAH, Motta E. Family centered-care at the neonatal intensive care unit (NICU): nurses' experiences. Enfermería: Cuidados Humanizados. 2020; 9(2): 170-190
Ghomi H, Yadegari F, Soleimani F, Knoll BL, Noroozi M, Mazouri A. The effects of premature infant oral motor intervention (PIOMI) on oral feeding of preterm infants: A randomized clinical trial. Int J Pediatr Otorhinolaryngol. 2019 May;120:202-209. doi: 10.1016/j.ijporl.2019.02.005. Epub 2019 Feb 5.
Fucile S, Gisel EG, McFarland DH, Lau C. Oral and non-oral sensorimotor interventions enhance oral feeding performance in preterm infants. Dev Med Child Neurol. 2011 Sep;53(9):829-835. doi: 10.1111/j.1469-8749.2011.04023.x. Epub 2011 Jun 27.
Lau C, Smith EO. A novel approach to assess oral feeding skills of preterm infants. Neonatology. 2011;100(1):64-70. doi: 10.1159/000321987. Epub 2011 Jan 5.
Majoli M, De Angelis LC, Panella M, Calevo MG, Serveli S, Knoll BL, Ramenghi LA. Parent-Administered Oral Stimulation in Preterm Infants: A Randomized, Controlled, Open-Label Pilot Study. Am J Perinatol. 2023 Jun;40(8):845-850. doi: 10.1055/s-0041-1731452. Epub 2021 Jun 28.
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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FMH-07-2021-IRB-929-M
Identifier Type: -
Identifier Source: org_study_id