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The Effects of Family Centered Intervention Program on Preterm Infants

G

Gazi University

Status

Completed

Conditions

Infant, Premature

Treatments

Other: Family based early intervention program (NDT-Bobath based)

Study type

Interventional

Funder types

Other

Identifiers

NCT03146351
MURATKOCYİGİT

Details and patient eligibility

About

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.

Full description

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.

Enrollment

52 patients

Sex

All

Ages

1 day to 6 months old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

52 participants in 2 patient groups

Early and moderate preterm group
Experimental group
Description:
Infants born before 34 weeks included in this group
Treatment:
Other: Family based early intervention program (NDT-Bobath based)
Late preterm group
Experimental group
Description:
Infants born between 34 and 37 weeks included in this group
Treatment:
Other: Family based early intervention program (NDT-Bobath based)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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