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

A RANDOMISED TRIAL OF PREVENTATIVE CARE AT HOME IN VERY PRETERM INFANTS ON NEUROSENSORY OUTCOME AT 2 YEARS OF AGE

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000492651

Acronym

Vibes plus

Enrollment

120

Registered

2005-09-23

Start date

2005-01-12

Completion date

2007-01-17

Last updated

2020-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Surviving infants < 30 weeks' gestational age will be randomly alloacted to a developmental care package delivered in the home or to standard follow-up care over the first year of life. The major endpoint is the Mental Developmental Index on the Bayley Scales of Infant Devlopment at 2 years of age, corrected for prematurity

Interventions

Developmental care administered in the home to surviving infants born < 30 weeks' gestational age by a physiotherapist and a psychologist over the first year of life.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

0 to 30 Weeks

Healthy volunteers

Inclusion criteria

Surviving infants < 30 weeks' gestational age at birth.

Exclusion criteria

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

Outcome results