More amino acids for prevention of extrauterine growth retardation in very low birth weight infants. A randomized controlled trial.

Phase 4

Completed

• Conditions: Growth of very low birth weight infants; Reproductive Health and Childbirth - Complications of newborn

• Registration Number: ACTRN12609001058268
• Lead Sponsor: Osp. Buon Consiglio

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-12-10
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

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

Inclusion Criteria

birth weight < 1500 gr
obtaining informed consent from parents

Exclusion Criteria

major congenital abnormality including known
chromosomal abnormality
twin-twin transfusion
intra-uterine transfusion or exchange transfusion
Rhesus iso-immunisation
significant multi-organ failure prior to trial entry

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
z-score of weight, height and head circumference.<br><br>We measured the deviation of the infant?s growth by reference for weight, length and head circumference. The differences were expressed as z score[at discharge from hospital<br>3, 6, 12 months of post concetional age (corrected age)]

Secondary Outcome Measures

Name	Time	Method
days to regain birth weight (BW), duration of parenteral nutrition (PN), length of hospital stay, incidence of necrotizing enterocolitis (NEC), retinopaty of prematurity (ROP), chronic lung disease (CLD), intraventricular hemorrage (IVH), periventricular leukomalacia (PVL)[at discharge from hospital]