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Infant Aquatics Neurodevelopment Premature Infants (IA-NPI)

S

Sheba Medical Center

Status

Unknown

Conditions

Cerebral Palsy
Development
Preterm Birth

Treatments

Other: Infant Massage
Other: Infant Aquatics

Study type

Interventional

Funder types

Other

Identifiers

NCT01779661
SHEBA-12-9524-OB-CTIL

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

1 to 4 weeks old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 2 patient groups

Infant Aquatics
Active Comparator group
Treatment:
Other: Infant Aquatics
Infant Massage
Active Comparator group
Description:
Infant Massage
Treatment:
Other: Infant Massage

Trial contacts and locations

1

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Central trial contact

Omer Bar-Yosef, MD PhD; Hagit Friedman, PhD

Data sourced from clinicaltrials.gov

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