Does increasing the protein content of human milk fortifier improve growth in preterm infants <33 weeks gestation? A randomised controlled trial.

Not Applicable

Completed

• Conditions: Premature infant growth; Diet and Nutrition - Other diet and nutrition disorders

• Registration Number: ACTRN12611001275954
• Lead Sponsor: Women's and Children's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-12-12
• Study Completion: 2013-09-02
• Last Update Posted: 16 March 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Infants <33 completed weeks gestation whose mothers intend to provide breast milk and have the written informed consent of their parents/guardians.

Exclusion Criteria

Infants with major congenital or chromosomal abnormalities known to affect growth or where protein therapy is contraindicated e.g. major heart defects, cystic fibrosis, phenylketonuria, disorders of the urea cycle. Infants likely to transfer to remote locations where weekly blood tests are unable to be performed.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Weight gain. Infants will be weighed weekly and weight gain from study start to discharge home used as primary outcome.[Term equivalent or discharge home, whichever occurs first.]

Secondary Outcome Measures

Name	Time	Method
ength and head circumference gain. Infant length and head circumference will be measured weekly from study start to discharge home used as primary outcome.[Estimated delivery date or discharge, whichever occurs first.]