Infant Aquatics Neurodevelopment Premature Infants (IA-NPI)

February 12, 2014 updated by: Sheba Medical Center

The Effect of Infant Aquatics for Neurodevelopment of Premature Infants

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Israel
      • Ramat-Gan,, Israel, 56210
        • Recruiting
        • Chaim Seba Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hagit Friedman, PhD
        • Principal Investigator:
          • Omer Bar-Yosef, MD PhD
        • Principal Investigator:
          • Caroline Barmatz, HT.BPT.MHA
        • Sub-Investigator:
          • Iris Morag, MD
        • Sub-Investigator:
          • Anat Lazits-Dor, BPT
        • Sub-Investigator:
          • Keren Mekadesh, RN BA
        • Sub-Investigator:
          • Zipora Strauss, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 week to 4 weeks (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Infant Aquatics
Other: 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
Active Comparator: Infant Massage
Other: Infant Massage
Infant Massage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Developmental assessment - a composite of several measures
Time Frame: 3 month

Developmental assessment at term and three month

  1. General Movements Neuromotor scale
  2. Neurological examination
3 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Developmental assessment - a composite of several measures
Time Frame: 18 month

Developmental assessment at 18 month

  1. IMP neuromotor developmental scale
  2. Griffith mental development scale
  3. Vineland adaptive behavior scale
18 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Collaborators

University of Haifa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Anticipated)

August 1, 2015

Study Registration Dates

First Submitted

January 27, 2013

First Submitted That Met QC Criteria

January 27, 2013

First Posted (Estimate)

January 30, 2013

Study Record Updates

Last Update Posted (Estimate)

February 13, 2014

Last Update Submitted That Met QC Criteria

February 12, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-12-9524-OB-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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