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Clinical Trials/ACTRN12621000364875
ACTRN12621000364875
Recruiting
N/A

The effect of telehealth for early intervention on neurodevelopmental outcomes of infants born very preterm and their parent’s well-being: a randomised controlled trial (TEDI-Prem)

The University of Melbourne0 sites466 target enrollmentMarch 31, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Not specified
Sponsor
The University of Melbourne
Enrollment
466
Status
Recruiting
Last Updated
4 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 31, 2021
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Infants admitted to the nurseries at The Royal Women’s, Royal Children’s, Monash Children’s, Joan Kirner Women’s and Children’s and Northern Hospitals, Victoria, Australia who are:
  • Born \<32 weeks’ gestational age
  • Medically stable and not ventilator\-dependent at recruitment (minimum age for enrolment 34 weeks' and maximum 40 weeks’ postmenstrual age)
  • Have one caregiver who speaks and can read English (as the web content and intervention materials are in English)
  • Able to participate in early intervention program for a 12 month period
  • There is no age limit of parents/caregivers who are eligible for participation.

Exclusion Criteria

  • Infants with a diagnosis of a congenital abnormality known to affect neurodevelopment, who require specific intervention such as infants with Trisomy 21\.
  • Infants who are planning to move overseas/interstate prior to primary outcome assessment at 12 months’ CA.
  • Parent not wanting to engage in telehealth intervention.

Outcomes

Primary Outcomes

Not specified

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