RECRUITING

Targeted Fortification of Donor Breast Milk in Preterm Infants

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study is a randomized controlled trial comparing standard fortification of donor breast milk to targeted fortification of donor breast milk in preterm infants. The purpose of the study is to determine if there is a benefit to target fortifying donor breast milk in the preterm population. The investigators hypothesize that infants receiving targeted fortification of donor breast milk will have improved growth compared to infants receiving standard fortification of donor breast milk.

Official Title

Targeted Fortification of Donor Breast Milk in Preterm Infants

Quick Facts

Study Start:2020-03-09
Study Completion:2025-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04294368

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.

Ages Eligible for Study:1 Day to 21 Days
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Premature infants born \</= 30 weeks gestational age
  2. * Birth Weight \</= 1500 grams
  1. * Parents do no consent to donor milk
  2. * Confounders for poor growth such as congenital heart disease, GI diagnoses such as gastroschisis and omphalocele, and or major congenital anomalies
  3. * Grade III or IV intraventricular hemorrhage diagnoses prior to randomization
  4. * Small for gestational age (\<3% on Fenton Growth Curve)
  5. * Failure to initiate fortified feeds prior to 3 weeks of life
  6. * Diagnosis of necrotizing entercolitis prior to randomization
  7. * Diagnosis of early onset sepsis confirmed with positive culture

Contacts and Locations

Study Contact

Jenny Taylor, MD
CONTACT
212-305-8500
jt3073@cumc.columbia.edu

Principal Investigator

Marianne Garland, MD
PRINCIPAL_INVESTIGATOR
Columbia University

Study Locations (Sites)

Columbia University Medical Center/ New York - Presbyterian
New York, New York, 10032
United States

Collaborators and Investigators

Sponsor: Columbia University

  • Marianne Garland, MD, PRINCIPAL_INVESTIGATOR, Columbia University

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 Registration Dates

Study Start Date2020-03-09
Study Completion Date2025-04

Study Record Updates

Study Start Date2020-03-09
Study Completion Date2025-04

Terms related to this study

Keywords Provided by Researchers

  • Human Milk Analyzer
  • Miris
  • Target Fortification
  • Targeted Fortification
  • Donor Breast Milk

Additional Relevant MeSH Terms

  • Prematurity; Extreme
  • Failure to Thrive in Newborn
  • Growth Retardation
  • Growth Failure
  • Infant Nutrition Disorders