Infant Aquatics Neurodevelopment Premature Infants

NCT ID: NCT01779661

Last Updated: 2014-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

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.

Detailed Description

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Conditions

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Cerebral Palsy Preterm Birth Development

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Infant Aquatics

Group Type ACTIVE_COMPARATOR

Infant Aquatics

Intervention Type OTHER

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

Infant Massage

Infant Massage

Group Type ACTIVE_COMPARATOR

Infant Massage

Intervention Type OTHER

Infant Massage

Interventions

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Infant Aquatics

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

Intervention Type OTHER

Infant Massage

Infant Massage

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

1 Week

Maximum Eligible Age

4 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Haifa

OTHER

Sponsor Role collaborator

Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chaim Seba Medical Center

Ramat Gan, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Hagit Friedman, PhD

Role: CONTACT

972-54-5841314

Omer Bar-Yosef, MD PhD

Role: CONTACT

972-52-6667344

Facility Contacts

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Omer Bar-Yosef, MD PhD

Role: primary

Caroline Barmatz, HT BPT MHA

Role: backup

Other Identifiers

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SHEBA-12-9524-OB-CTIL

Identifier Type: -

Identifier Source: org_study_id

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