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

Primary Purpose

Neonatal Abstinence Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Human Milk
Standard of Care
Sponsored by
The University of Texas Health Science Center at San Antonio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neonatal Abstinence Syndrome focused on measuring human milk

Eligibility Criteria

undefined - 48 Hours (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 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.
  2. Infant feeding was NPO (nil per os) or consisted of 100% human milk diet prior to randomization.
  3. Parent(s) willing to sign informed consent.
  4. Parent(s) willing to comply with study follow-up procedures.

Exclusion Criteria:

  1. Term infants >2 days old at the time of evaluation for NAS.
  2. <37 weeks gestation.
  3. Outborn infants who received enteral nutrition at the other institution prior to transfer. If it is uncertain if infant received even 1 bottle or a small amount of formula, infants will be excluded.

  4. Major congenital abnormalities:

    1. Confirmed or suspected major genetic abnormalities (lethal or with extremely low probability for survival).
    2. Chromosomal abnormalities: Trisomies (13, 18, 21 etc.) deletions or translocations (Turner/Williams Syndrome, DiGeorge, to name a few).
    3. Major organ system abnormalities not related to a genetic syndrome that are lethal or have extremely low probability for survival (i.e, bilateral kidney intrinsic disease, pulmonary hypoplasia, CNS (central nervous system) malformations: Arnold Chiari, myelomengoceles, hydranencephaly, squizencephaly, holoprocencephaly).
  5. Any comorbidity or significant clinical event prior to enrollment, deemed by the Investigator as likely to affect survival or intestinal health.
  6. Legally Authorized Representative(s) unwilling to comply with an exclusive human milk diet either in the form of mother's milk, human milk-based human milk fortifier, human milk based caloric fortifier or donor human milk during the initial hospitalization period and through the 28 day feeding period or hospital discharge, whichever comes first.

Sites / Locations

  • University Health System, Robert B GreenRecruiting
  • MARC - The University of Texas Health Science CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Exclusive Human Milk

Maternal human milk or Formula

Arm Description

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

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

Outcomes

Primary Outcome Measures

Length of Hospital Stay
Length of stay in infants at risk for neonatal abstinence syndrome who are fed an exclusive human milk diet from birth through the 28-day feeding period or until hospital discharge, whichever comes first

Secondary Outcome Measures

Growth Velocity Rate
rate of linear growth and incremental rate of head circumference growth; gm/week, cm/week and z-score from World Health Organization (WHO) growth charts
Body Composition Percentage Fat
Body composition using Peapod at 28 days or discharge. The PEA POD uses the principles of wholebody densitometry to determine body composition. In this technique, body mass and body volume are measured (both performed within the unit). Once body density (Density = Mass/Volume) is determined, the PEA POD uses known (or user customized) densitometric equations to calculate percent Fat.
Body Composition Percentage Fat Free Mass
Body composition using Peapod. The PEA POD uses the principles of wholebody densitometry to determine body composition. In this technique, body mass and body volume are measured (both performed within the unit). Once body density (Density = Mass/Volume) is determined, the PEA POD uses known (or user customized) densitometric equations to calculate percent Fat-Free Mass.

Full Information

First Posted
August 6, 2020
Last Updated
October 4, 2023
Sponsor
The University of Texas Health Science Center at San Antonio
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1. Study Identification

Unique Protocol Identification Number
NCT04508348
Brief Title
Clinical Trial to Decrease Length of Stay in Infants With Neonatal Abstinence Syndrome With an Exclusive Human Milk Diet
Official Title
A Single Center Randomized Controlled Trial to Decrease Length of Stay in Infants With Neonatal Abstinence Syndrome (NAS) With an Exclusive Human Milk Diet
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 31, 2020 (Actual)
Primary Completion Date
August 2026 (Anticipated)
Study Completion Date
August 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Health Science Center at San Antonio

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A clinical trial to evaluate length of stay, growth velocity and clinical outcomes in infants with neonatal abstinence syndrome receiving an exclusive human milk diet. Human milk is defined as expressed human milk or donor milk and its derivatives, human milk-based fortifier and human milk caloric fortifier.
Detailed Description
This is a single blinded (physician investigator), randomized, controlled trial to evaluate length of stay in infants with NAS and an exclusive human milk diet during their initial hospitalization after birth and through the 28 days of life or hospital discharge, whichever comes first. Subjects will be randomized to one of two groups after at birth. Parents who decline participation for their infants in the study will be asked to consent to data gathering on their infants who will be treated and fed per institutional practice. The data on these individuals will be summarized and evaluated descriptively in comparison with the actual trial results. All experimental group participants will receive exclusive maternal human milk or donor human milk prior to randomization. Once randomized, patients in Group One will receive an exclusive human milk diet throughout the 28-day feeding period or until hospital discharge, whichever comes first. Patients in Group Two (Control Group) will receive maternal human milk or formula (per standard of care). Fortification will be implemented with a standard protocol.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Abstinence Syndrome
Keywords
human milk

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A randomized, blinded, controlled trial
Masking
Investigator
Masking Description
Physician Investigator will be blinded
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exclusive Human Milk
Arm Type
Active Comparator
Arm Description
Group One will receive an exclusive human milk diet throughout the 28-day feeding period or until hospital discharge
Arm Title
Maternal human milk or Formula
Arm Type
Other
Arm Description
Group Two (Control Group) will receive maternal human milk or formula (per standard of care).
Intervention Type
Other
Intervention Name(s)
Human Milk
Other Intervention Name(s)
100% Human Milk
Intervention Description
Exclusive Human Milk diet
Intervention Type
Other
Intervention Name(s)
Standard of Care
Other Intervention Name(s)
Mother's milk and/or formula
Intervention Description
This diet will include mother's milk and/or formula
Primary Outcome Measure Information:
Title
Length of Hospital Stay
Description
Length of stay in infants at risk for neonatal abstinence syndrome who are fed an exclusive human milk diet from birth through the 28-day feeding period or until hospital discharge, whichever comes first
Time Frame
Baseline to 28 days
Secondary Outcome Measure Information:
Title
Growth Velocity Rate
Description
rate of linear growth and incremental rate of head circumference growth; gm/week, cm/week and z-score from World Health Organization (WHO) growth charts
Time Frame
Baseline to 28 days
Title
Body Composition Percentage Fat
Description
Body composition using Peapod at 28 days or discharge. The PEA POD uses the principles of wholebody densitometry to determine body composition. In this technique, body mass and body volume are measured (both performed within the unit). Once body density (Density = Mass/Volume) is determined, the PEA POD uses known (or user customized) densitometric equations to calculate percent Fat.
Time Frame
28 days
Title
Body Composition Percentage Fat Free Mass
Description
Body composition using Peapod. The PEA POD uses the principles of wholebody densitometry to determine body composition. In this technique, body mass and body volume are measured (both performed within the unit). Once body density (Density = Mass/Volume) is determined, the PEA POD uses known (or user customized) densitometric equations to calculate percent Fat-Free Mass.
Time Frame
28 Days

10. Eligibility

Sex
All
Maximum Age & Unit of Time
48 Hours
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Infant feeding was NPO (nil per os) or consisted of 100% human milk diet prior to randomization. Parent(s) willing to sign informed consent. Parent(s) willing to comply with study follow-up procedures. Exclusion Criteria: Term infants >2 days old at the time of evaluation for NAS. <37 weeks gestation. Outborn infants who received enteral nutrition at the other institution prior to transfer. If it is uncertain if infant received even 1 bottle or a small amount of formula, infants will be excluded. Major congenital abnormalities: Confirmed or suspected major genetic abnormalities (lethal or with extremely low probability for survival). Chromosomal abnormalities: Trisomies (13, 18, 21 etc.) deletions or translocations (Turner/Williams Syndrome, DiGeorge, to name a few). Major organ system abnormalities not related to a genetic syndrome that are lethal or have extremely low probability for survival (i.e, bilateral kidney intrinsic disease, pulmonary hypoplasia, CNS (central nervous system) malformations: Arnold Chiari, myelomengoceles, hydranencephaly, squizencephaly, holoprocencephaly). Any comorbidity or significant clinical event prior to enrollment, deemed by the Investigator as likely to affect survival or intestinal health. Legally Authorized Representative(s) unwilling to comply with an exclusive human milk diet either in the form of mother's milk, human milk-based human milk fortifier, human milk based caloric fortifier or donor human milk during the initial hospitalization period and through the 28 day feeding period or hospital discharge, whichever comes first.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cynthia Blanco, MD, MSCI-TS
Phone
210-567-5246
Email
blanco@uthscsa.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Diana Anzueto Guerra
Phone
210-567-5254
Email
anzuetod@uthscsa.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia Blanco, MD, MSCI-TS
Organizational Affiliation
University of Texas Health at San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Health System, Robert B Green
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78207
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diana Anzueto Guerra
Phone
210-567-5254
Email
anzuetod@uthscsa.edu
First Name & Middle Initial & Last Name & Degree
Cynthia Blanco, MD, MSCI-TS
Phone
210-567-5246
Email
blanco@uthscsa.edu
First Name & Middle Initial & Last Name & Degree
Cynthia L Blanco, MD
Facility Name
MARC - The University of Texas Health Science Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diana Anzueto Guerra
Phone
210-567-5254
Email
anzuetod@uthscsa.edu
First Name & Middle Initial & Last Name & Degree
Cynthia Blanco, MD, MSCI-TS
Phone
210-567-5246
Email
blanco@uthscsa.edu
First Name & Middle Initial & Last Name & Degree
Cynthia Blanco, MD, MSCI-TS

12. IPD Sharing Statement

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

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