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Completed

NCT Number: NCT03146351

The Effects of Family Centered Intervention Program on Preterm Infants

Infant born preterm have an increased risk of adverse long-term developmental outcomes.The risk associated with preterm birth increase as gestational age decreases, and vulnerability remains in moderate and early preterm (<34 weeks) and late preterm (>34 weeks). There are many studies in the literature showed that the prevalence of developmental delay increases with premature birth. However, there is no study in the literature investigates effect of early intervention program motor performance in subgroups of preterm infants. Hence the aim of this study is to evaluate the differences in effects of early intervention program on motor development in early and moderate (<34 weeks) and late preterm infants.

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Key information

Age range

1 day–6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gazi Universitesi, Saglik Bilimleri Fakultesi, Fizyoterapi ve Rehabilitasyon Bolumu

Ankara, Turkey (Türkiye)

About this study

Fifty-two preterm infants corrected age less than 6 months included in this study. They were separated by their birth weeks. Babies with gestational ages between 34-36 weeks and 6 days (including the given days) are categorized as late preterm, while those born before 34 weeks are grouped as moderate and early preterm. Each group contains 26 infants.

First, sociodemographic information and histories of babies are obtaining. Ages and contact information of the parents are recording. Prenatal and natal risk factors of the mothers are querying. Gestational ages and height, weight, and head circumferences of babies at birth are recording. Number of pregnancies, live births and abortions, type of delivery, multiple pregnancies for mothers as well as consanguinity between parents are asking.The Alberta Infant Motor Scale is using to evaluate spontaneous motor movements of the baby. After the detailed examination, intervention program set up for infants. Both groups receive 3 months family based intervention program.

After the intervention program, both groups re-examined.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Born before 37 gestational weeks,
  • Accepting to join the study
  • Corrected age 6 months or less

Exclusion criteria

  • Having high risk factors (e.g. grade 3 or more intraventricular hemorrhage, PVL, serious seizure)
  • Born after 37 weeks
  • Corrected age greater than 6 months

Treatment and study plan

Family based early intervention program (NDT-Bobath based)

Other

Family based early intervention program is NDT - Bobath based home program. Physiotherapist teaches principles of the treatment to infants' family. Family applies the program at home.

Primary outcomes

  1. Motor performance using the Alberta Infant Motor Scale

    Time frame: This study is planned to be completed within 6 months

    Alberta Infant Motor Scale is used to examine motor performance.

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Official study title

The Effects of Family Centered Physiotherapy Program on Preterm Infants

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 9, 2017
Registry last updated
May 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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