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Early Physical Therapy Intervention in Preterm Infants

U

University of Vic - Central University of Catalonia

Status

Completed

Conditions

NICU
Preterm Infant
Home
Motor Development
Early Intervention
Physical Therapy

Treatments

Other: Usual Care
Other: Physical Therapy Early Intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT03313427
PTNEO-001

Details and patient eligibility

About

The hypothesis of this study is that early physical therapy intervention, initiated during the NICU stay and up to 2 months corrected age, based on the family-centered model, could promote preterm infants motor development in short-term (2 months corrected age) and long-term (8 months corrected age).

There is a high evidence level of different systematic reviews, which support the effectivity of early intervention with preterm infants.

The principal aim of this randomized controlled trial is to evaluate the effectiveness of early physiotherapy intervention to promote motor development in preterm infants at 2 and 8 months corrected age.

The secondary purpose is to study the motor development of those preterm infants who received early physical therapy intervention.

Enrollment

48 patients

Sex

All

Ages

28 to 34 weeks old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Preterm infants, gestational age between 28-34 weeks
  • Families with ability to take care of the child, without chronic or mental illness
  • Long-term parental presence in the hospital (at least 10h/day)

Exclusion criteria

  • Children diagnosed with congenital disease or brain injury (LPV, HIV), before or during the study
  • Children undergoing major surgery (cardiac intervention, Ductus, thoracic intervention)
  • Children with musculoskeletal deformities

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Double Blind

48 participants in 2 patient groups

Intervention
Experimental group
Description:
Usual care Early physical therapy intervention at the UCIN and after discharge, at home; based on the family-centered model.
Treatment:
Other: Physical Therapy Early Intervention
Control
Other group
Description:
Usual care
Treatment:
Other: Usual Care

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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