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

December 1, 2018 updated by: Dr Deepak Kumar, MetroHealth Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

At birth, and after written informed consent, investigators will encourage opiate dependent mothers to breast feed if appropriate in accordance with hospital NAS management guidelines (sober for at least 4-6 months, enrolled in a drug treatment program, HIV negative). If mother is unable to breast feed and or chooses formula feeding for the infant or the infant needs supplemental formula due to inadequate lactation or poor weight gain, then the infant will be randomized to either receive blinded "low lactose formula Similac Sensitive" or "regular cow mild based formula Similac Advance". These will be simply labelled as Formula A and formula B. The randomization will be done using computer generated random number coupled with stratified balanced blocked methodology. Recent reformulations by Abbott Nutrition in the US market nation wide has resulted in "low lactose formula Similac Sensitive" being made 19 cal/oz or 20 cal/oz or "regular cow mild based formula Similac Advance" which is now only available as 19 cal/oz instead of 20 cal/oz. This change in calorie density has occured to reflect newer data suggested that human breast milk has 19 cal/oz instead of 20 cal/oz as believed previously. Abbott has continued to make 20 cal/oz Similac sensitive because many many providers across the country are using this for NAS babies. There are some differences in other carbohydrates other than lactose (both have <1% lactose) in the two Similac Sensitive 19 and 20 cal/oz. The calorie difference is of no clinical significance in term infants because they modulate their volume of milk consumed.

After recruitment and randomization at birth, infants will be fed every 2-3 hrs or on demand and will also be observed for NAS score every 2-3 hours starting soon after birth. Infants will receive their "medical provider directed" standard pharmacological and non-pharmacological treatment.

Those who do not demonstrate NAS, will be discharged after 5-7 days of observation. Study formula will be discontinued or may be continued if they or their provider chose to do so.

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 and medical care providers may use formula of their preference. However investigators will offer 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.

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44019
        • MetroHealth Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Low lactose 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" which arrives from milk lab labeled as formula "A" or formula "B".
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".
Active Comparator: Regular formula
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
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".

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative dose of morphine required to treat NAS.
Time Frame: 14 days of age
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.
Time Frame: 14 days of age
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MetroHealth Medical Center

Investigators

  • Principal Investigator: Deepak Kumar, MD, MetroHealth Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 9, 2014

Primary Completion (Actual)

June 30, 2018

Study Completion (Actual)

June 30, 2018

Study Registration Dates

First Submitted

May 6, 2017

First Submitted That Met QC Criteria

May 25, 2018

First Posted (Actual)

June 8, 2018

Study Record Updates

Last Update Posted (Actual)

December 4, 2018

Last Update Submitted That Met QC Criteria

December 1, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB14-00005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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