Hydrolized Protein Formula for Premature Infants

NCT01156493 | Completed

• 1 other identifier: 20090579
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 1

Brief Summary

Premature infants fed with a protein hydrolyzed formula will have better tolerance needing shorter time to achieve full feeds when compared to those fed with an intact protein formula.

Conditions

Prematurity

Keywords

feeding intolerance; prematurity

Outcome Measures

Primary Outcomes (1)

• Time to achieve full feeds

  Number of days from initiating oral feeds to achieve full feeds

  Average 1 to 3 weeks of life

Secondary Outcomes (1)

• Postnatal days to achieve full feeds

  Average: 1- 3 weeks of age

Study Arms (2)

Protein Hydrolyzed Formula

EXPERIMENTAL

Infants assigned to this group will receive HP formula when breast milk not available or indicated to receive formula by the attending physician

Other: Protein Hydrolyzed Premature Formula

Control

NO INTERVENTION

Infants in this group will receive standard prematrue formula when no breast milk available or indicated by the attending physician

Interventions

Protein Hydrolyzed Premature Formula OTHER

Infants will be fed with a protein hydrolyzed premature formula until they reach full feeds

Protein Hydrolyzed Formula

Eligibility Criteria

• Age: 3 Days - 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Birth weight between 500 -1500g and \< 32 weeks GA who survive more than 3 days.
• Has not yet started enteral full feeds.
• Study explained and parent/caregiver demonstrating understanding of the given information.
• Informed consent signed.

You may not qualify if:

• Chromosomal anomalies.
• Major congenital anomalies (complex cardiac anomalies, congenital hydrocephalus, renal dysplasia).
• Congenital (e.g. jejunal atresia) and acquired (e.g. GI perforation) gastrointestinal pathology precluding oral feed and/or requiring major surgical or medical intervention.
• Parental refusal.
• Prior enrollment into a conflicting clinical trial. Conflicting clinical trial will be those in which the intervention could modify the outcome of the present study, for example studies aimed to accelerate feeds and or improve tolerance.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami/Holtz Children's Hospital/Neonatal Intensive Care Unit

Miami, Florida, 33136, 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

• Teresa Del Moral, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Standard Formula
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Protein Hydrolized Formula

Study Record Dates

• First Submitted: July 1, 2010
• First Posted: July 2, 2010
• Study Start: July 1, 2010
• Primary Completion: October 1, 2013
• Study Completion: September 1, 2015
• Last Updated: May 10, 2017

Record last verified: 2015-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)