Role of Low Lactose Infant Formula In The Management of Neonatal Abstinence Syndrome

Completed · Not applicable

Conditions studied: Neonatal Abstinence Syndrome

In brief

Currently Morphine and or Methadone are the most commonly used drugs in the treatment for NAS along with supportive care. Many care providers offer tolerance "low lactose" formula to these infants to alleviate gastrointestinal symptoms. There are no clinical studies to support this practice and it is currently unknown that low lactose formula really helps or not in management of NAS. This is a Randomized Double Blind Clinical Trial to assess the role of low lactose formula versus standard (regular) formula in managing NAS.

Key facts

Study ID

NCT03549936

Run by

MetroHealth Medical Center

People needed

74

Starts

2014-07-09

Expected to finish

2018-06-30

Last updated by the study team

2018-12-04

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Intrauterine exposure of opiate and related drugs-morphine
• Late preterm or full term (36-42 weeks of gestation)

You may not qualify if…

• Major congenital anomalies
• Post-surgical cases
• Major respiratory, cardiovascular, neurological or metabolic disorders
• Less than 36 completed weeks of gestation

Where it is running

• MetroHealth Medical Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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