Infant Aquatics Neurodevelopment Premature Infants

Study Overview
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Brief Summary
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The objective of this research is to examine the effect of Infant Aquatics on the development of and neurodevelopment of preterm and near-term infants, using the GM as prognostic estimation of future development. Preterm infants, a continuously growing population, are at high risk for neurodevelopment impairments ranging from minor neurological dysfunction (MND) to cerebral palsy (CP), mainly due to developmental brain injury. Infant Aquatics have been found to benefit and promote infant development. The support and sensory stimulation of the water may improve the development the sensory, motor, as well as, autonomic system of preterm infants. The study will compare intervention by Infant Aquatics to infant massage. The intervention in both methods will start at 36 weeks gestational age for 3 months and will consist of sessions with a therapist every 2 weeks. Development will be assessed and compared at 3, 8 and 18 months using Infant Motor Pattern method, Griffith developmental scales and Vineland adaptive behavior scales.

Official Title
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The Effect of Infant Aquatics for Neurodevelopment of Premature Infants

Conditions
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Cerebral Palsy, Preterm Birth, Development

Intervention / Treatment
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* Other: Infant Aquatics
* Other: Infant Massage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Major inclusion criteria: Infants who are hemodynamic stable, no seizures or apnea attacks, IVH/PVH grade < 3, without diagnoses of chromosomal abnormalities, infants whose parents want to cooperate, will be included. These criteria follow our aim to include vulnerable groups of infants for which research results may dramatically promote development. Exclusion Criteria: infants whose parents are not able to understand research goals and refuse to cooperate, infants with seizures or apnea attacks, IVH/PVH grade >or =3, with diagnoses of chromosomal abnormalities.

Ages Eligible for Study
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Minimum Age: 1 Week
Maximum Age: 4 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Infant Aquatics<br> | Other: Infant Aquatics<br>* Infant Aquatics in this study is composed of a set of pre-structured movements and techniques of relaxation, through harmonic integration of various approaches, each having a role in a specific time-window or in the infant's developmental sequence along study interventional timeline<br>|
| Active Comparator: Infant Massage<br>Infant Massage | Other: Infant Massage<br>* Infant Massage<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Developmental assessment - a composite of several measures | Developmental assessment at term and three month General Movements Neuromotor scale Neurological examination | 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Developmental assessment - a composite of several measures | Developmental assessment at 18 month IMP neuromotor developmental scale Griffith mental development scale Vineland adaptive behavior scale | 18 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neurodevelopment, Infant-Aquatics, Prematurity