Post-Discharge Growth of Infants Who Received Donor Human Milk Products in the Neonatal Intensive Care Unit (NICU)

NCT01483079 | Active Not Recruiting

• 1 other identifier: H-29522
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

Human milk feeding is associated with great benefits to the health and development of infants, especially in premature infants. Some mothers are unable or unwilling to provide breast milk to their infant. The use of donor human milk products for very low birth weight infants as an alternative to cow milk has risen dramatically in the past year. Purpose: To evaluate post-discharge growth and neurodevelopment of infants less than or equal to 1250 grams birth weight receiving an exclusive human milk protein diet.

Conditions

Prematurity

Keywords

donor human milk products; post-discharge; growth; development

Outcome Measures

Primary Outcomes (3)

• Post-discharge growth and neurodevelopment

  Per the protocol procedures, growth and development will be assessed at each study visit.

  12-15 months of age

• Post-discharge growth and neurodevelopment

  Per the protocol procedures, growth and development will be assessed at each study visit.

  18-22 months of age

• Post-discharge growth and neurodevelopment

  Per the protocol procedures, growth and development will be assessed at each study visit.

  5 years of age

Study Arms (1)

Former preterm infants

A cohort of infants less than or equal to 1250 grams birth weight that received donor human milk products in the NICU will be recruited and followed. Some infants recruited will be from a previously studied population of very low birth weight infants receiving donor human milk products in the NICU at Texas Children's Hospital.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A cohort of infants less than or equal to 1250 grams birth weight that received donor human milk products in the NICU will be recruited and followed. Some infants recruited will be from a previously studied population of very low birth weight infants receiving donor human milk products in the NICU at Texas Children's Hospital.

You may qualify if:

• Premature infants (\<37 weeks gestation) with a birth weight less than or equal to 1250 grams birth weight that received donor human milk products in the NICU during hospitalization.

You may not qualify if:

• Infants with a birth weight greater than 1250 grams.
• Infants transferred from an outside hospital to TCH at greater than one week of age.
• Infants who do not achieve any enteral feeds by 4 weeks of age.
• Infants with major congenital anomalies.
• Infants who die within the first 48 hours of admission to TCH.

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Amy B Hair, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: November 9, 2011
• First Posted: December 1, 2011
• Study Start: December 1, 2011
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 29, 2026

Record last verified: 2026-01

Locations

US (1)