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| Name | Class |
|---|---|
| Hospital Sant Joan de Deu | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Usual care Early physical therapy intervention at the UCIN and after discharge, at home; based on the family-centered model. |
|
| Control | Other | Usual care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical Therapy Early Intervention | Other | At the UCIN:
At home: Psychomotor Development Program for the baby; comprised of different exercises, in different phases, depending on child maturation stage. Started after hospital discharge until 2 months corrected age. |
| Measure | Description | Time Frame |
|---|---|---|
| Motor development. | Assessed by the Alberta Infant Motor Scale (AIMS). Total maximum score 40 points. Higher values represent a better outcome. | 2 months corrected age and 8 months corrected age |
| Measure | Description | Time Frame |
|---|---|---|
| Movement quality. | Assessed by the General Movements Assessment. The assessment provide the quality of the movement (suboptimal/optimal/pathological). | 40 weeks postmenstrual age and 2 months corrected age |
| Gross motor and fine motor function. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Sant Joan de Deu | Barcelona | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35740832 | Derived | Ochandorena-Acha M, Terradas-Monllor M, Lopez Sala L, Cazorla Sanchez ME, Fornaguera Marti M, Munoz Perez I, Agut-Quijano T, Iriondo M, Casas-Baroy JC. Early Physiotherapy Intervention Program for Preterm Infants and Parents: A Randomized, Single-Blind Clinical Trial. Children (Basel). 2022 Jun 15;9(6):895. doi: 10.3390/children9060895. |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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|
| Usual Care | Other | NICU usual care |
|
Assessed by the Bayley Scale of Infant Development III. Percentile ranks from 1 to 99. Higher percentile represent a better outcome
| 8 months corrected age |
| Development and risk of development delay. | Assessed by the Ages and Stages Questionnaires Third Edition (ASQ-3). 30 questions covering 5 domains of development: communication, gross motor, fine motor, problem-solving and adaptive skills. | 1 months corrected age and 8 months corrected age |
| Mothers' stress index. | Assessed by the Parents Stress Index - Short Form. Composed of 36 items with a Likert-type answer format of five options. | after the intervention, 3 months corrected age |
| D000091642 | Urogenital Diseases |