Trial Outcomes & Findings for Oropharyngeal Administration of Colostrum to Extremely Low Gestational Age Newborns (NCT NCT01536093)

NCT ID: NCT01536093

Last Updated: 2014-08-13

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 48 participants
• Primary outcome timeframe: 2 weeks of age
• Results posted on: 2014-08-13

Participant Flow

Participant milestones

Measure	Colostrum oropharyngeal administration of own mother's colostrum oropharyngeal administration of own mother's colostrum: application of 0.2 mL of colostrum to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours.	Placebo oropharyngeal administration of sterile water oropharyngeal administration of sterile water: application of 0.2 mL of sterile water to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours.
Overall Study STARTED	24	24
Overall Study COMPLETED	21	21
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Measure	Colostrum oropharyngeal administration of own mother's colostrum oropharyngeal administration of own mother's colostrum: application of 0.2 mL of colostrum to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours.	Placebo oropharyngeal administration of sterile water oropharyngeal administration of sterile water: application of 0.2 mL of sterile water to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours.
Overall Study Death	1	2
Overall Study absence of maternal colostrum	2	0
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Oropharyngeal Administration of Colostrum to Extremely Low Gestational Age Newborns

Baseline characteristics by cohort

Measure	Colostrum n=21 Participants oropharyngeal administration of own mother's colostrum oropharyngeal administration of own mother's colostrum: application of 0.2 mL of colostrum to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours.	Placebo n=21 Participants oropharyngeal administration of sterile water oropharyngeal administration of sterile water: application of 0.2 mL of sterile water to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours.	Total n=42 Participants Total of all reporting groups
Age, Continuous	26.1 weeks STANDARD_DEVIATION 1.4 • n=5 Participants	26.0 weeks STANDARD_DEVIATION 1.4 • n=7 Participants	26.1 weeks STANDARD_DEVIATION 1.4 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants
Birth weight	862.2 g STANDARD_DEVIATION 234.8 • n=5 Participants	842.4 g STANDARD_DEVIATION 250.4 • n=7 Participants	849.3 g STANDARD_DEVIATION 239.8 • n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks of age

Outcome measures

Measure	Colostrum n=21 Participants oropharyngeal administration of own mother's colostrum oropharyngeal administration of own mother's colostrum: application of 0.2 mL of colostrum to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours.	Placebo n=21 Participants oropharyngeal administration of sterile water oropharyngeal administration of sterile water: application of 0.2 mL of sterile water to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours.
Urinary Secretary IgA Concentration at 2 Weeks of Age	233.8 ng per g creatinine Standard Deviation 37.4	48.3 ng per g creatinine Standard Deviation 24.1

SECONDARY outcome

Timeframe: 1 week of age

Outcome measures

Measure	Colostrum n=21 Participants oropharyngeal administration of own mother's colostrum oropharyngeal administration of own mother's colostrum: application of 0.2 mL of colostrum to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours.	Placebo n=21 Participants oropharyngeal administration of sterile water oropharyngeal administration of sterile water: application of 0.2 mL of sterile water to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours.
Urinary Secretary IgA Concentration at 1 Week of Age	71.4 ng per g creatinine Standard Deviation 33.1	26.5 ng per g creatinine Standard Deviation 6.7

SECONDARY outcome

Timeframe: 2 week of age

Outcome measures

Measure	Colostrum n=21 Participants oropharyngeal administration of own mother's colostrum oropharyngeal administration of own mother's colostrum: application of 0.2 mL of colostrum to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours.	Placebo n=21 Participants oropharyngeal administration of sterile water oropharyngeal administration of sterile water: application of 0.2 mL of sterile water to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours.
Salivary TGF-beta 1 Concentration at 2 Week of Age	39.2 ug/mL Standard Deviation 6.3	69.7 ug/mL Standard Deviation 12.7

SECONDARY outcome

Timeframe: 2 weeks of age

Outcome measures

Measure	Colostrum n=21 Participants oropharyngeal administration of own mother's colostrum oropharyngeal administration of own mother's colostrum: application of 0.2 mL of colostrum to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours.	Placebo n=21 Participants oropharyngeal administration of sterile water oropharyngeal administration of sterile water: application of 0.2 mL of sterile water to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours.
Salivary IL-8 Concentration at 2 Weeks of Age	2.58 ng/mL Standard Deviation 1.01	4.90 ng/mL Standard Deviation 1.19

SECONDARY outcome

Timeframe: 1 week of age

Outcome measures

Measure	Colostrum n=21 Participants oropharyngeal administration of own mother's colostrum oropharyngeal administration of own mother's colostrum: application of 0.2 mL of colostrum to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours.	Placebo n=21 Participants oropharyngeal administration of sterile water oropharyngeal administration of sterile water: application of 0.2 mL of sterile water to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours.
Concentration of Urinary Lactoferrin	3.51 ug per g creatinine Standard Deviation 1.32	0.98 ug per g creatinine Standard Deviation 0.28

SECONDARY outcome

Timeframe: 2 weeks of age

Outcome measures

Measure	Colostrum n=21 Participants oropharyngeal administration of own mother's colostrum oropharyngeal administration of own mother's colostrum: application of 0.2 mL of colostrum to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours.	Placebo n=21 Participants oropharyngeal administration of sterile water oropharyngeal administration of sterile water: application of 0.2 mL of sterile water to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours.
Concentration of Urinary IL-1 Beta	55.25 ug per g creatinine Standard Deviation 7.12	91.80 ug per g creatinine Standard Deviation 11.86

SECONDARY outcome

Timeframe: 1 week of age

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 weeks of age

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 2 months of age

day of life when the baby reaches full enteral feeding, defined as a volume above 120~130mL/kg/day

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 4 months of age

days from admission to discharge from NICU

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: from date of randomization up to 4 months of age

numbers of documented sepsis events defined as isolation of the microorganism from ≥ 1 blood culture + ≥ 1 clinical symptoms or sign (fever, hypothermia, apnea, bradycardia, hypo-/hyperglycemia)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: from date of randomization up to 4 months of age

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: from date of randomization up to 4 months of age

numbers of documented pneumonia events those accompanied with increased tracheal secretion, increased ventilatory setting and treated with antibiotics

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 4 months of age

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 4 months of age

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 4 months of age

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: from the start date of oropharyngeal administration of colostrum or sterile water to 1 week of age

category of adverse effects

1. general - fever or hypothermia, rash

2. respiratory & cardiovascular - apnea, tachypnea, desaturation, hypotension, bradycardia, tachycardia

3. gastrointestinal - abdominal distension, bilious gastric remain, vomiting, bloody stool, necrotizing enterocolitis

4. renal - oliguria (urine output < 1.0cc/kg/day)

5. laboratory - hypo-/hyper-natremia, acidosis, hypercarbia

Outcome measures

Outcome data not reported

Adverse Events

Colostrum

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Juyoung Lee

Seoul National University College of Medicine

Phone: 82-31-787-7301

Email: lamb4122@snu.ac.kr

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place