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The Norwegian Physical Therapy Study in Preterm Infants

NCT01089296 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 153

Last updated 2023-01-06

No results posted yet for this study

Summary

This is a pragmatic randomized controlled study. The purpose of the study is to evaluate the practice and effect of customised physiotherapy on preterm infants'motor development when the intervention is performed over a period of three weeks while the infant resides in the neonatal intensive care unit. The study will also attempt to analyze the parents' experiences in being actively involved in education and practice of the intervention designed to promote the child's motor development, and the effects on the parent-child relationship in the short and long term.The children are followed up until a corrected age of two years. This study consists of a pragmatic randomized controlled trial and a qualitative study.

Conditions

Interventions

OTHER

Individually customized physiotherapy

Main elements in the intervention are postural support and facilitating techniques. The intervention will be carried out twice a day over a three-week period if the infant's condition allows it. The length of each treatment session will be adjusted dependent on the infant's response and condition. Maximum treatment time is 10 minutes.

Sponsors & Collaborators

  • University of Tromso

    collaborator OTHER

  • St. Olavs Hospital

    collaborator OTHER

  • University of Illinois at Chicago

    collaborator OTHER

  • Oslo University Hospital

    collaborator OTHER

  • University Hospital of North Norway

    lead OTHER

Principal Investigators

  • Gunn K. Øberg, PhD · University of Tromsø / University Hospital of North Norway

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
7 Days
Max Age
10 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-18
Primary Completion
2016-11-30
Completion
2016-11-30

Countries

  • Norway

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01089296 on ClinicalTrials.gov