Early Routine vs. Selective Human Milk Fortification in Extremely Preterm Infants
Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The aim of the project is to study the effects of fortification (using a Human Milk Donor Fortifier) of an exclusive preterm human milk diet on outcome of extremely preterm neonates, born at less or equal to 27 weeks.
Eligibility
Participation Requirements
Sex: All
Maximum Age: 6 days
Healthy Volunteers: f
View:
• All extremely preterm infants with gestational age less or equal to 27 weeks who are admitted to the NICU prior to day of life seven and the first enteral feeding
Locations
United States
New York
Crouse Hospital
RECRUITING
Syracuse
Contact Information
Primary
Bouraa Bou Aram, MD
bouraabouarammd@crouse.org
(315)470-7379
Backup
Steven J Gross, MD
stevengrossmd@crouse.org
(315)470-7379
Time Frame
Start Date: 2020-02-15
Estimated Completion Date: 2027-02-01
Participants
Target number of participants: 200
Treatments
Experimental: Early Routine Fortification
Human Milk Donor Fortifier added to preterm human milk (maternal or donor) when feeds of 150 ml/kg/day are reached (120Kcal/kg/day)
Active_comparator: Selective Fortification
Human Milk Donor Fortifier added to preterm human milk (maternal or donor) only for weight gain less than 15g/kg/day after full feeds of 180 ml/kg/day are achieved (120 Kcal/kg/day). If milk of any infant in the selective fortification group gets fortified the volume will be decreased to 150 ml/kg/day to keep the total caloric intake equal.
Related Therapeutic Areas
Sponsors
Leads: Crouse Hospital