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

NCT03549936 | Completed

• 1 other identifier: IRB14-00005
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

NAS, low lactose formula

Outcome Measures

Primary Outcomes (2)

• Cumulative dose of morphine required to treat NAS.

  Every dose of morphine required to treat NAS over first 14 days of life will be noted and total cumulative dose administered will be observed. We expect infants on low lactose formula versus regular formula will require lower cumulative dose of morphine during first 2 weeks of life.

  14 days of age

• Highest dose of morphine required to treat NAS.

  Every dose of morphine required to treat NAS over first 14 days of life will be noted. We expect infants on low lactose formula versus regular formula will require lower maximal dose of morphine.

  14 days of age

Study Arms (2)

Low lactose formula

ACTIVE COMPARATOR

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

Other: Low lactose or regular formula

Regular formula

ACTIVE COMPARATOR

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

Other: Low lactose or regular formula

Interventions

Low lactose or regular formula OTHER

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".

Low lactose formula; Regular formula

Eligibility Criteria

• Age: 1 Minute - 7 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• MetroHealth Medical Center: lead

Study Sites (1)

MetroHealth Medical Center

Cleveland, Ohio, 44019, United States

Location

Related Publications (1)

• Pahl A, Young L, Buus-Frank ME, Marcellus L, Soll R. Non-pharmacological care for opioid withdrawal in newborns. Cochrane Database Syst Rev. 2020 Dec 21;12(12):CD013217. doi: 10.1002/14651858.CD013217.pub2.

  PMID: 33348423 DERIVED

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

Study Officials

• Deepak Kumar, MD

  MetroHealth Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Infants who develop NAS will continue to receive blinded formula as part of non-pharmacological treatment and will also receive pharmacological treatment (morphine/methadone) as per hospital guidelines directed by their medical care providers. Pharmacological treatment will be optimized and weaned as per standard hospital guidelines. Use of blinded formula A or B will be continued until 2 weeks of age at which point its use as study intervention will be completed. After this point, parents/home care providers and medical care providers may use formula of their preference. However we will offer them a choice of continuing the blinded formula until the infant is discharged at which point standard formula will have to be initiated. General clinical data will be collected at discharge including length of stay and weight.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neonatologist

Model Details: Randomized Double Blind Clinical trial on Role of Low Lactose Formula In the Management of Neonatal Abstinence Syndrome

Study Record Dates

• First Submitted: May 6, 2017
• First Posted: June 8, 2018
• Study Start: July 9, 2014
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: December 4, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)