Improving neurobehavioural development in preterm infants

Environmental intervention, using parent sensitivity training, to improve neurobehavioural development in preterm infants: A randomised controlled trial'.

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12606000412538

Enrollment

160

Registered

2006-09-21

Start date

2006-10-01

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

To date, intervention foci to improve neurobehavioural outcomes in preterm infants have been primarily medical. The intervention developed for this study is based on the observation of severe dysregulation in premature infants and the potential of sensitive maternal-infant interaction to modulate the damaging effects of stress on infants' general and brain development. In essence we aim to train mothers to be therapists to their own hospitalised preterm infant. The development of infants of intervention and control mothers will be assessed and compared at several ages until 24 months corrected age.

Interventions

Intensive parent sensitivity training in first 12 weeks following premature birth aimed at reducing infant stress.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

0 to No maximum

Healthy volunteers

Inclusion criteria

Mothers of singleton or twin infants born at less than or equal to 30 weeks gestational age will be included.

Exclusion criteria

Families living outside a 100km radius of Melbourne, those with insufficient English, and those whose infants have a congenital abnormality will be excluded. Any mothers whose young age precludes them from giving fully informed consent will also be excluded.

Outcome results