Trial Outcomes & Findings for Donor Human Milk in Neonatal Abstinence Syndrome (NCT NCT02182973)

NCT ID: NCT02182973

Last Updated: 2019-04-12

Results Overview

Minimum score:0; Maximum score 13. Higher scores mean more GI distress

Recruitment status

COMPLETED

Target enrollment

12 participants

Primary outcome timeframe

2 weeks

Results posted on

2019-04-12

Participant Flow

Historical controls are not considered to be enrolled in the study. Thus, they are not counted in the enrollment numbers.

Participant milestones

Participant milestones
Measure	Donor Human Milk Infants identified with neonatal abstinence syndrome requiring pharmacologic management and who will not be fed own mother's milk donor human milk: Infants with NAS requiring pharmacologic management will be fed donor human milk instead of formula for 2 weeks. GI-subscores from the Finnegan NAS Scoring system will be computed.	Historical Control Infants from the previous year with NAS but fed formula.
Overall Study STARTED	12	9
Overall Study COMPLETED	9	9
Overall Study NOT COMPLETED	3	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Donor Human Milk Infants identified with neonatal abstinence syndrome requiring pharmacologic management and who will not be fed own mother's milk donor human milk: Infants with NAS requiring pharmacologic management will be fed donor human milk instead of formula for 2 weeks. GI-subscores from the Finnegan NAS Scoring system will be computed.	Historical Control Infants from the previous year with NAS but fed formula.
Overall Study Withdrawal by Subject	3	0

Baseline Characteristics

3 subjects were withdrawn by a parent prior to completing the study.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 2 weeks

Minimum score:0; Maximum score 13. Higher scores mean more GI distress

Outcome measures

Outcome measures
Measure	Donor Human Milk n=9 Participants Infants identified with neonatal abstinence syndrome requiring pharmacologic management and who will not be fed own mother's milk donor human milk: Infants with NAS requiring pharmacologic management will be fed donor human milk instead of formula for 2 weeks. GI-subscores from the Finnegan NAS Scoring system will be computed.	Historical Controls n=9 Participants Historical groups with NAS and receiving formula
Percentage of Infants Achieving a GI Subscore >2 Over the Study Period	39 Percentage of participants	61 Percentage of participants

SECONDARY outcome

Timeframe: 2 weeks

Change in weight from study day 1 to study day 14 (grams/day) Weight day 14 - weight day 1 divided by 14

Outcome measures

Outcome measures
Measure	Donor Human Milk n=9 Participants Infants identified with neonatal abstinence syndrome requiring pharmacologic management and who will not be fed own mother's milk donor human milk: Infants with NAS requiring pharmacologic management will be fed donor human milk instead of formula for 2 weeks. GI-subscores from the Finnegan NAS Scoring system will be computed.	Historical Controls n=9 Participants Historical groups with NAS and receiving formula
Weight Change at 2 Weeks	19.1 grams/day Standard Deviation 13.1	20.5 grams/day Standard Deviation 3.0

SECONDARY outcome

Timeframe: 2 weeks

Change in head circumference from day 1 to day 14 (cm/wk)

Outcome measures

Outcome measures
Measure	Donor Human Milk n=9 Participants Infants identified with neonatal abstinence syndrome requiring pharmacologic management and who will not be fed own mother's milk donor human milk: Infants with NAS requiring pharmacologic management will be fed donor human milk instead of formula for 2 weeks. GI-subscores from the Finnegan NAS Scoring system will be computed.	Historical Controls n=9 Participants Historical groups with NAS and receiving formula
Head Circumference Change at 2 Weeks	0.4 cm/wk Standard Deviation 0.1	0.6 cm/wk Standard Deviation 0.2

Adverse Events

Donor Human Milk

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Historical Control

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

Paula Radmacher

University of Louisville

Phone: 5028525532

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Donor Human Milk n=9 Participants Term infants identified with neonatal abstinence syndrome requiring pharmacologic management and who will not be fed own mother's milk Donor human milk: Infants with NAS requiring pharmacologic management will be fed donor human milk instead of formula for 2 weeks. GI-subscores from the Finnegan NAS Scoring system will be computed.	Historical Control n=9 Participants Term infants identified with NAS requiring pharmacologic management in the previous year receiving formula feedings.	Total n=18 Participants Total of all reporting groups
Age, Categorical <=18 years	9 Participants n=5 Participants • 3 subjects were withdrawn by a parent prior to completing the study.	9 Participants n=7 Participants • 3 subjects were withdrawn by a parent prior to completing the study.	18 Participants n=5 Participants • 3 subjects were withdrawn by a parent prior to completing the study.
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants • 3 subjects were withdrawn by a parent prior to completing the study.	0 Participants n=7 Participants • 3 subjects were withdrawn by a parent prior to completing the study.	0 Participants n=5 Participants • 3 subjects were withdrawn by a parent prior to completing the study.
Age, Categorical >=65 years	0 Participants n=5 Participants • 3 subjects were withdrawn by a parent prior to completing the study.	0 Participants n=7 Participants • 3 subjects were withdrawn by a parent prior to completing the study.	0 Participants n=5 Participants • 3 subjects were withdrawn by a parent prior to completing the study.
Age, Continuous	38.8 weeks STANDARD_DEVIATION 1.0 • n=5 Participants	38.8 weeks STANDARD_DEVIATION 1.4 • n=7 Participants	38.8 weeks STANDARD_DEVIATION 1.2 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants	0 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	9 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment United States	9 Participants n=5 Participants • 3 infants were withdrawn from the study by the parent early in the study and were not in the final analyzed group.	9 Participants n=7 Participants • 3 infants were withdrawn from the study by the parent early in the study and were not in the final analyzed group.	18 Participants n=5 Participants • 3 infants were withdrawn from the study by the parent early in the study and were not in the final analyzed group.
Birth weight	3091 grams STANDARD_DEVIATION 350 • n=5 Participants	2934 grams STANDARD_DEVIATION 495 • n=7 Participants	3013 grams STANDARD_DEVIATION 423 • n=5 Participants