Donor Human Milk in Neonatal Abstinence Syndrome

NCT02182973 | Completed Results

• 1 other identifier: NAS 052014
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Abstinence Syndrome

Keywords

neonatal abstinence syndrome, infant opiate withdrawal

Outcome Measures

Primary Outcomes (1)

• Percentage of Infants Achieving a GI Subscore >2 Over the Study Period

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

  2 weeks

Secondary Outcomes (2)

• Weight Change at 2 Weeks

  2 weeks

• Head Circumference Change at 2 Weeks

  2 weeks

Study Arms (1)

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

Interventions

donor human milk DIETARY_SUPPLEMENT

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.

Also known as: Co-op donor milk (Medolac Laboratories)

DHM

Eligibility Criteria

• Age: 38 Weeks - 42 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Neolac Inc dba Medolac Laboratories: lead
• University of Louisville: collaborator

Study Sites (1)

University of Louisville

Louisville, Kentucky, 40292, United States

Location

Related Publications (16)

• Patrick SW, Schumacher RE, Benneyworth BD, Krans EE, McAllister JM, Davis MM. Neonatal abstinence syndrome and associated health care expenditures: United States, 2000-2009. JAMA. 2012 May 9;307(18):1934-40. doi: 10.1001/jama.2012.3951. Epub 2012 Apr 30.

  PMID: 22546608 BACKGROUND

• Nestler EJ. Molecular mechanisms of opiate and cocaine addiction. Curr Opin Neurobiol. 1997 Oct;7(5):713-9. doi: 10.1016/s0959-4388(97)80094-3.

  PMID: 9384550 BACKGROUND

• Kreek MJ, Bart G, Lilly C, LaForge KS, Nielsen DA. Pharmacogenetics and human molecular genetics of opiate and cocaine addictions and their treatments. Pharmacol Rev. 2005 Mar;57(1):1-26. doi: 10.1124/pr.57.1.1.

  PMID: 15734726 BACKGROUND

• Kron RE, Finnegan LP, Kaplan SL, Litt M, Phoenix MD. The assessment of behavioral change in infants undergoing narcotic withdrawal: comparative data from clinical and objective methods. Addict Dis. 1975;2(1-2):257-75.

  PMID: 1163368 BACKGROUND

• Neonatal drug withdrawal. American Academy of Pediatrics Committee on Drugs. Pediatrics. 1998 Jun;101(6):1079-88.

  PMID: 9614425 BACKGROUND

• Section on Breastfeeding. Breastfeeding and the use of human milk. Pediatrics. 2012 Mar;129(3):e827-41. doi: 10.1542/peds.2011-3552. Epub 2012 Feb 27.

  PMID: 22371471 BACKGROUND

• Behnke M, Smith VC; Committee on Substance Abuse; Committee on Fetus and Newborn. Prenatal substance abuse: short- and long-term effects on the exposed fetus. Pediatrics. 2013 Mar;131(3):e1009-24. doi: 10.1542/peds.2012-3931. Epub 2013 Feb 25.

  PMID: 23439891 BACKGROUND

• Chasnoff IJ, Lewis DE, Squires L. Cocaine intoxication in a breast-fed infant. Pediatrics. 1987 Dec;80(6):836-8.

  PMID: 3684393 BACKGROUND

• COBRINIK RW, HOOD RT Jr, CHUSID E. The effect of maternal narcotic addiction on the newborn infant; review of literature and report of 22 cases. Pediatrics. 1959 Aug;24(2):288-304. No abstract available.

  PMID: 13674828 BACKGROUND

• Perez-Reyes M, Wall ME. Presence of delta9-tetrahydrocannabinol in human milk. N Engl J Med. 1982 Sep 23;307(13):819-20. doi: 10.1056/NEJM198209233071311. No abstract available.

  PMID: 6287261 BACKGROUND

• Steiner E, Villen T, Hallberg M, Rane A. Amphetamine secretion in breast milk. Eur J Clin Pharmacol. 1984;27(1):123-4.

  PMID: 6489423 BACKGROUND

• Rodriguez-Palmero M, Koletzko B, Kunz C, Jensen R. Nutritional and biochemical properties of human milk: II. Lipids, micronutrients, and bioactive factors. Clin Perinatol. 1999 Jun;26(2):335-59.

  PMID: 10394491 BACKGROUND

• Sheard NF, Walker WA. The role of breast milk in the development of the gastrointestinal tract. Nutr Rev. 1988 Jan;46(1):1-8. doi: 10.1111/j.1753-4887.1988.tb05343.x. No abstract available.

  PMID: 3277089 BACKGROUND

• Billeaud C, Guillet J, Sandler B. Gastric emptying in infants with or without gastro-oesophageal reflux according to the type of milk. Eur J Clin Nutr. 1990 Aug;44(8):577-83.

  PMID: 2209513 BACKGROUND

• Cavell B. Gastric emptying in infants fed human milk or infant formula. Acta Paediatr Scand. 1981 Sep;70(5):639-41.

  PMID: 7324911 BACKGROUND

• 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.

  RESULT

MeSH Terms

Conditions

Neonatal Abstinence Syndrome

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Paula Radmacher
• Organization: University of Louisville

paula.radmacher@louisville.edu

5028525532

Study Officials

• Lori Devlin, DO, MHA

  University of Louisville Division of Neonatal Medicine

  PRINCIPAL INVESTIGATOR

• Paula G Radmacher, MSPH, Ph.D.

  University of Louisville Division of Neonatal Medicine

  STUDY DIRECTOR

• Scott Duncan, MD

  University of Louisville Division of Neonatal Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2014
• First Posted: July 8, 2014
• Study Start: June 1, 2014
• Primary Completion: August 1, 2017
• Study Completion: September 9, 2017
• Last Updated: April 12, 2019
• Results First Posted: April 12, 2019

Record last verified: 2019-04

Locations

US (1)