THE EFFECT OF PRETERM BIRTH ON OUTCOME - A RANDOMISED TRIAL OF PREVENTATIVE CARE

Phase 4

Completed

• Conditions: SURVIVING VERY PRETERM INFANTS(<30 WEEKS' GESTATIONAL AGE); Reproductive Health and Childbirth - Complications of newborn

• Registration Number: ACTRN12605000492651
• Lead Sponsor: Royal Women's Hospital, Melbourne

Brief Summary

This study demonstrated that an early preventive care program for very preterm infants (<30 weeks of gestation) and their families improved infants’ behavioral outcomes and reduced primary caregivers’ anxiety and depression at corrected age of 2, and had some continued benefits as the children reached school-age.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-09-23
• Study Completion: 2015-09-16
• Last Update Posted: 24 February 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Surviving infants < 30 weeks' gestational age at birth.

Exclusion Criteria

Recognisable congenital anomaly or chromosomal disorder universally associated with adverse developmental outcome.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Developmental quotient at 2 years of age[At 2 years of age]

Secondary Outcome Measures

Name	Time	Method
eurosensory disability[At 2 years of age.];Motor and cognitive development[At 2 years of age.];Behavioural and emotional functioning[At 2 years of age.];Communication skills[At 2 years of age.];Mother-child interactions[At 2 years of age.]