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Donor Human Milk in Neonatal Abstinence Syndrome (DHM&NAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02182973
Recruitment Status : Completed
First Posted : July 8, 2014
Results First Posted : April 12, 2019
Last Update Posted : April 12, 2019
Sponsor:
Collaborator:
University of Louisville
Information provided by (Responsible Party):
Neolac Inc dba Medolac Laboratories

Brief Summary:

This study is designed to develop pilot data on the acceptability and benefit of donor human milk for infants undergoing pharmacologic treatment for NAS. Specifically, gastrointestinal (GI) sub-scores, as well as total scores, will be compared between infants historically fed formula and those enrolled in a 2-week donor human milk study period.

Purpose of study: to test the following null hypothesis:

Infants with a diagnosis of neonatal abstinence syndrome (NAS) due to in-utero exposure to opiates, fed donor human milk, will have similar GI/feeding sub-scores of the Finnegan scoring tool when compared to (historic) infants fed formula.

A rejection of the null hypothesis will be used to design a randomized trial of donor human milk in infants with NAS.


Condition or disease Intervention/treatment
Neonatal Abstinence Syndrome Dietary Supplement: donor human milk

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Study Type : Observational
Actual Enrollment : 12 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Donor Human Milk for Infants With Neonatal Abstinence Syndrome
Actual Study Start Date : June 2014
Actual Primary Completion Date : August 1, 2017
Actual Study Completion Date : September 9, 2017

Group/Cohort Intervention/treatment
DHM
Infants identified with neonatal abstinence syndrome requiring pharmacologic management and who will not be fed own mother's milk
Dietary Supplement: 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.

Other Name: Co-op donor milk (Medolac Laboratories)




Primary Outcome Measures :
  1. Percentage of Infants Achieving a GI Subscore >2 Over the Study Period [ Time Frame: 2 weeks ]
    Minimum score:0; Maximum score 13. Higher scores mean more GI distress


Secondary Outcome Measures :
  1. Weight Change at 2 Weeks [ Time Frame: 2 weeks ]
    Change in weight from study day 1 to study day 14 (grams/day) Weight day 14 - weight day 1 divided by 14

  2. Head Circumference Change at 2 Weeks [ Time Frame: 2 weeks ]
    Change in head circumference from day 1 to day 14 (cm/wk)



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Ages Eligible for Study:   38 Weeks to 42 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Infants with a diagnosis of neonatal abstinence syndrome (NAS) due to in-utero exposure to opiates, fed donor human milk, will have similar GI/feeding sub-scores of the Finnegan scoring tool when compared to (historic) infants fed formula.
Criteria

Inclusion Criteria:

  • Term infants (>37 completed weeks) with a diagnosis of NAS, due to maternal use of opiates (only)
  • Infants will have had moderate to severe NAS symptoms (Finnegan scores >8) that required pharmacologic therapy but have been stabilized (captured) on oral morphine (Finnegan scores less than 8 for 24 hours)
  • Breastfeeding is contraindicated or the mother has chosen formula feeding for her baby

Exclusion Criteria:

  • Preterm infants (<37 completed weeks at birth)
  • Infants with intrauterine growth restriction (BW <10th percentile for gestational age)
  • Mother is providing her own milk

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02182973


Locations
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United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40292
Sponsors and Collaborators
Neolac Inc dba Medolac Laboratories
University of Louisville
Investigators
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Principal Investigator: Lori Devlin, DO, MHA University of Louisville Division of Neonatal Medicine
Study Director: Paula G Radmacher, MSPH, Ph.D. University of Louisville Division of Neonatal Medicine
Principal Investigator: Scott Duncan, MD University of Louisville Division of Neonatal Medicine
  Study Documents (Full-Text)

Documents provided by Neolac Inc dba Medolac Laboratories:

Publications of Results:
Alexander C, Radmacher P, Devlin L. Donor human milk may decrease severe gastrointestinal distress in infants with neonatal abstinence syndrome. Pregnancy and neonatal medicine 2017; 1(1):11-15.

Other Publications:

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Responsible Party: Neolac Inc dba Medolac Laboratories
ClinicalTrials.gov Identifier: NCT02182973    
Other Study ID Numbers: NAS 052014
First Posted: July 8, 2014    Key Record Dates
Results First Posted: April 12, 2019
Last Update Posted: April 12, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Neolac Inc dba Medolac Laboratories:
neonatal abstinence syndrome, infant opiate withdrawal
Additional relevant MeSH terms:
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Neonatal Abstinence Syndrome
Syndrome
Disease
Pathologic Processes
Infant, Newborn, Diseases
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders