Clinical Trial: Donor Human Milk in Neonatal Abstinence Syndrome

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

Official Title: Donor Human Milk for Infants With Neonatal Abstinence Syndrome

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.


Detailed Summary:

Background

Neonatal Abstinence Syndrome (NAS) is a drug withdrawal syndrome that occurs primarily after antenatal exposure to opiates. Symptoms may be present at birth, but often peak at 48-72 after delivery. The onset of symptoms is affected by the half-life of the opiate used during pregnancy in combination with maternal and infant metabolism. The incidence of NAS has increased substantially since 2000 both nationally and in the Commonwealth of Kentucky, leading to a significant increase in healthcare resource utilization and (Figure 1).

The 2012 National Survey on Drug Use and Health found that illicit drug abuse affected ~130,000 pregnancies in the United States from 2011-2012 and that approximately 20% of those pregnancies (26,000) involved opiates. (SAMSA Center for Behavioral Health Statistics and Quality, National Survey on Drug Use and Health, 2009-2012). Patrick et al. utilized the Kids' Inpatient Database (KID) from the Agency for Health Care Research and Quality to evaluate the incidence of maternal opiate use during pregnancy (1). He and his team noted a substantial increase in the number of mothers using opiates - 1.19 per 1000 hospital births in 2000 to 5.63 per 1000 hospital births in 2009. As a result, there was an increased diagnosis of NAS from 1.20 per 1000 hospital births in 2000 to 3.39 per 1000 hospital births in 2009. This is a 2.8-fold increase which means that every hour of every day, 1 neonate in the United States undergoes drug withdrawal.

The Kentucky Injury Prevention and Research Center reported that 824 infants in the state of Kentucky were hospitalized for neonatal withdrawal after exposure to opiates in 2012. This represents an 18% increase from 2011 and a 4.5 fold increase from 2005. (Kentucky Injury Prevention and Research Center. Data fo
Sponsor: Neolac Inc dba Medolac Laboratories

Current Primary Outcome: Change in GI subscore from Baseline at 2 weeks [ Time Frame: 2 weeks ]

Change in GI subscores from study day 1 to study day 14


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Weight gain at 2 weeks [ Time Frame: 2 weeks ]
    Change in weight from study day 1 to study day 14 (grams/day)
  • Head circumference growth at 2 weeks [ Time Frame: 2 weeks ]
    Change in head circumference from day 1 to day 14 (cm/wk)


Original Secondary Outcome: Same as current

Information By: Neolac Inc dba Medolac Laboratories

Dates:
Date Received: May 29, 2014
Date Started: June 2014
Date Completion: August 2017
Last Updated: October 31, 2016
Last Verified: October 2016