Prediction of mild developmental delay and typical outcome in at risk preterm infants.

In very preterm and very low birth weight infants, will neurological, neurobehavioural, motor and perceptual assessment completed by 16 weeks post term, allow accurate prediction of typical development and mild developmental delay at 2 years corrected age?

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12614000480684

Acronym

PREMTiME

Enrollment

104

Registered

2014-05-09

Start date

2014-08-19

Completion date

2018-11-30

Last updated

2020-09-14

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

Conditions

None listed

Brief summary

The risk of developmental delay in the preterm population increases as gestational age decreases. As milder delays often go undetected, the challenge in premature infant follow up is early detection without over servicing. The primary aim of this study is to determine if early clinical assessment completed by 16 weeks post term will allow robust prediction of typical development and mild developmental delay at 2 years corrected age. Earlier prediction will enable clinicians to safely plan discharge for low risk infants from follow up services and facilitate the prioritisation of resources towards infants identified as likely to have mild to moderate or more severe outcomes. As developmental progress is dependent upon many variables, a combination of clinical tools including neurological assessment, motor assessment and parent questionnaires will be used to predict outcome at 2 years. Likewise a comprehensive selection of outcome measures will be used at 2 years to enable identification of subtle delays. Early findings will be compared to development at 2 years corrected age to determine any predictive relationship for typical outcomes and mild developmental delay. As families, clinicians and health services continue to want and need more immediate information regarding the short and long term outcomes of preterm infants, finding the best clinical biomarkers has the potential to streamline and effectively prioritise premature infant follow up programs.

Interventions

Early assessment measures: 1. For Infants; Premie- Neuro Asssessment at 34-35 weeks General Movement Assessment at 34-35 weeks and 2,5,11-12 and 16 weeks corrected age Infant Sensory Profile2 at 16 weeks corrected age Alberta Infant Motor Scale at 16 weeks corrected age NICU Network Neurobehavioural Scale at 2 or 5 weeks corrected age 2. For Parents; Edinburgh Post Natal Depression Scale at 34-35 weeks Social Risk Index at 34-35 weeks Impact on Families Scale at 34-35 weeks

Eligibility

Sex/Gender

All

Age

0 to 37 Weeks

Healthy volunteers

Inclusion criteria

Infants born at less than 1500g or less than 32 weeks gestation who are admitted to the the Special Care Nursery at Nambour Hospital, the Sunshine Coast University Hospital and the Buderim Private Hospital

Exclusion criteria

Infants with major congenital or chromosomal abnormalities Families living outside a 100km radius from the Nambour General Hospital Families where no English is spoken

Outcome results