Infant Aquatics Neurodevelopment Premature Infants

Not Applicable

• Conditions: Development; Cerebral Palsy; Preterm Birth
• Interventions: Other: Infant Aquatics; Other: Infant Massage

• Registration Number: NCT01779661
• Lead Sponsor: Sheba Medical Center

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-01-27
• Study First Submitted QC: 2013-01-27
• Study First Posted: 2013-01-30
• Study Start: 2013-04
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-12
• Last Update Posted: 2014-02-13
• Primary Completion: 2015-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Infant Aquatics	Infant Aquatics	-
Infant Massage	Infant Massage	Infant Massage

Primary Outcome Measures

Name	Time	Method
Developmental assessment - a composite of several measures	3 month	Developmental assessment at term and three month; 1. General Movements Neuromotor scale; 2. Neurological examination

Secondary Outcome Measures

Name	Time	Method
Developmental assessment - a composite of several measures	18 month	Developmental assessment at 18 month; 1. IMP neuromotor developmental scale; 2. Griffith mental development scale; 3. Vineland adaptive behavior scale

Trial Locations

Locations (1)

Chaim Seba Medical Center; 🇮🇱 Ramat-Gan,, Israel