Hydrolized Protein Formula for Premature Infants

Randomized Trial of Hydrolyzed Protein Premature Formula

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.

Study Overview

• Status: Completed
• Conditions: Prematurity
• Intervention / Treatment: Other: Protein Hydrolyzed Premature Formula

Detailed Description

The study formula is a 100% whey protein partially hydrolyzed (vs 60/40 Whey:Casein ratio of regular premature formulas) Because the tolerance and availability of breast milk is not predictable at the time of enrollment all the eligible premature infants will be randomized and assigned to the study or control group. Infants will receive formula, either because breast milk is not available or because indicated by the attending physician and switched to formula, They will be fed, depending of the group to what they are assigned, with either the PH formula for the study group or regular premature formula for the control group.

Randomization and blinding All eligible infants with parental consent will be randomized to either the study group to receive protein hydrolyzed formula (PH group) or to the control group to receive standard premature formula. Randomization will be stratified by 2 birth weight categories (500-1000 g and 1001-1500 g). The purpose of such stratification is to avoid imbalance between groups for factors that may influence outcome and is based on the different morbidity in different birth weight categories.

Masked randomization will be performed in a way that avoids the possibility of knowledge of treatment assignment at the time that eligibility is assessed and consent is sought. Only the person in charge of preparing the control or study formula will be aware of the infant's assignment group. Caregivers will remain masked to treatment group.

Study population Preterm newborns admitted to the neonatal intensive care unit with a birth weight 500-1500 g and who survive more than 3 days.

• Study Type: Interventional
• Enrollment (Actual): 137
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami/Holtz Children's Hospital/Neonatal Intensive Care Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 days to 6 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Protein Hydrolyzed Formula; 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; Infants will be fed with a protein hydrolyzed premature formula until they reach full feeds
No Intervention: Control; Infants in this group will receive standard prematrue formula when no breast milk available or indicated by the attending physician

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to achieve full feeds	Number of days from initiating oral feeds to achieve full feeds	Average 1 to 3 weeks of life

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postnatal days to achieve full feeds	number of days from birth to achieve full feeds	Average: 1- 3 weeks of age

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Teresa Del Moral, MD, University of Miami

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: July 1, 2010
• First Submitted That Met QC Criteria: July 1, 2010
• First Posted (Estimate): July 2, 2010

Study Record Updates

• Last Update Posted (Actual): May 10, 2017
• Last Update Submitted That Met QC Criteria: May 9, 2017
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: prematurity; feeding intolerance
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: 20090579

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No