Use of Human Milk Cream to Decrease Length of Stay in Extremely Premature Infants

Summary

At present, widespread use of the human milk-based caloric supplement (cream) has not occurred, particularly in infants with bronchopulmonary dysplasia (BPD), and further data are needed to support its adoption as a standard care practice.

The investigators hypothesize that infants who receive an exclusive human milk (HM)-based diet with the addition of a HM-derived cream caloric supplement (Cream group) will have a shorter length of initial hospital stay compared to infants receiving the standard regimen of an exclusive HM-based diet (Control group). The investigators hypothesize that the effects of the cream caloric supplement will be greater in the subgroup of infants who develop BPD so the relationship will be evaluated between Cream Supplement study group and postmenstrual age (PMA) at discharge and the incidence of BPD. Investigators will also evaluate the post-hospital discharge growth, body composition, and neurodevelopmental outcomes at 18 to 24 months CGA of the infants 500-1250 grams BW who received an exclusive human milk diet including cream supplement or control in the NICU.

Conditions

• Bronchopulmonary Dysplasia

Interventions

DIETARY_SUPPLEMENT

Cream Supplement group

Infants in the intervention arm will receive the cream supplement in addition to the standard regimen.

Sponsors & Collaborators

• Prolacta Bioscience

  collaborator INDUSTRY

• Medical University Innsbruck

  collaborator OTHER

• The University of Texas Health Science Center, Houston

  collaborator OTHER

• Michigan State University

  collaborator OTHER

• Akron Children's Hospital

  collaborator OTHER

• Timpanogos Regional Hospital

  collaborator UNKNOWN

• Orlando Health, Inc.

  collaborator OTHER

• St. Louis Children's Hospital

  collaborator OTHER

• Baylor Scott and White Health

  collaborator OTHER

• Westchester Medical Center

  collaborator OTHER

• Unity Health Toronto

  collaborator OTHER

• St. John Hospital & Medical Center

  collaborator OTHER

• Texas Tech University Health Sciences Center, El Paso

  collaborator OTHER

• Cook Children's Medical Center

  collaborator OTHER

• University of Oklahoma

  collaborator OTHER

• Baylor College of Medicine

  lead OTHER

Principal Investigators

• Amy B Hair, MD · Texas Children's Hospital, Baylor College of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Max Age

14 Days

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-06-10

Primary Completion

2019-06-25

Completion

2025-12-30

Countries

• United States
• Austria

Study Locations