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Human Milk Diet for Neonatal Abstinence Syndrome

N/A

Recruiting

Led By Cynthia Blanco, MD, MSCI-TS

Research Sponsored by The University of Texas Health Science Center at San Antonio

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Term infants (≥37 and 0/7 weeks gestational age) ≤ 2 days old with a diagnosis or at risk for neonatal abstinence syndrome. Can be enrolled ante-natally.

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 28 days

Awards & highlights

Study Summary

This trial will study whether an exclusive human milk diet can help improve outcomes for infants with neonatal abstinence syndrome.

Who is the study for?

This trial is for full-term infants (born at ≥37 weeks) who are 2 days old or less, diagnosed with or at risk for neonatal abstinence syndrome. Infants must not have any major genetic abnormalities, lethal organ defects, or conditions affecting survival/intestinal health. Parents must agree to an exclusive human milk diet and follow-up procedures.Check my eligibility

What is being tested?

The study tests whether an exclusive diet of human milk can reduce hospital stay length and improve growth in newborns with neonatal abstinence syndrome. Human milk includes mother's expressed milk, donor milk, and its derivatives like fortifiers designed specifically from human milk.See study design

What are the potential side effects?

Since the intervention involves feeding infants with human breastmilk instead of formula or other nutrition sources, there are no direct 'side effects' as typically associated with medications; however, individual tolerance to the diet may vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My newborn is at risk for or diagnosed with neonatal abstinence syndrome and is 2 days old or younger.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 28 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~28 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Length of Hospital Stay

Secondary outcome measures

Body Composition Percentage Fat

Body Composition Percentage Fat Free Mass

Growth Velocity Rate

Side effects data

From 2016 Phase 4 trial • 8 Patients • NCT01833897

38%

sedation

25%

headache

13%

phosphenes

13%

hypomania

100%

80%

60%

40%

20%

Study treatment Arm

Ketamine and DCS Treatment

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Maternal human milk or FormulaExperimental Treatment1 Intervention

Group Two (Control Group) will receive maternal human milk or formula (per standard of care).

Group II: Exclusive Human MilkActive Control1 Intervention

Group One will receive an exclusive human milk diet throughout the 28-day feeding period or until hospital discharge

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center at San AntonioLead Sponsor

452 Previous Clinical Trials

91,314 Total Patients Enrolled

Cynthia Blanco, MD, MSCI-TSPrincipal InvestigatorUniversity of Texas Health at San Antonio

1 Previous Clinical Trials

328 Total Patients Enrolled

Media Library

Human Milk (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04508348 — N/A

Neonatal Abstinence Syndrome Research Study Groups: Exclusive Human Milk, Maternal human milk or Formula

Neonatal Abstinence Syndrome Clinical Trial 2023: Human Milk Highlights & Side Effects. Trial Name: NCT04508348 — N/A

Human Milk (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04508348 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are enrollment slots still available for this research initiative?

"Affirmative, the clinicaltrials.gov database signifies that this trial is now looking for individuals to participate in it. It was initially posted on August 31st 2020 and last modified October 3rd 2022. The investigators are currently recruiting 100 participants from two distinct medical institutions."

Answered by AI

What is the recruitment quota for this medical assessment?

"Affirmative, the records displayed on clinicaltrials.gov verify that this medical investigation is currently enrolling volunteers. The trial was initially advertised on August 31st 2020 and later revised October 3rd 2022; it seeks to recruit a total of 100 participants across 2 different sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Clinical Trial to Decrease Length of Stay in Infants With Neonatal Abstinence Syndrome With an Exclusive Human Milk Diet

2020. "Clinical Trial to Decrease Length of Stay in Infants With Neonatal Abstinence Syndrome With an Exclusive Human Milk Diet". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04508348.