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

NCT03549936 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2018-12-04

No results posted yet for this study

Summary

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.

Conditions

  • Neonatal Abstinence Syndrome

Interventions

OTHER

Low lactose or regular formula

If infant is not breast feeding and parents plan to formula feed, following written informed consent, infant is randomized to receive "low lactose formula" or "regular formula" which arrives from milk lab blinded and labeled as formula "A" or formula "B".

Sponsors & Collaborators

  • MetroHealth Medical Center

    lead OTHER

Principal Investigators

  • Deepak Kumar, MD · MetroHealth Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Minute
Max Age
7 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-07-09
Primary Completion
2018-06-30
Completion
2018-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03549936 on ClinicalTrials.gov