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Infant Aquatics Neurodevelopment Premature Infants (IA-NPI)

This study is not yet open for participant recruitment.
Verified March 2013 by Sheba Medical Center
Sponsor:
Collaborator:
University of Haifa
Information provided by (Responsible Party):
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01779661
First received: January 27, 2013
Last updated: March 21, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention
Cerebral Palsy
Prematurity
Development
Hydrotherapy
 Other: Infant Aquatics
Other: Infant Massage

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Infant Aquatics for Neurodevelopment of Premature Infants

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Developmental assessment - a composite of several measures [ Time Frame: 3 month ] [ Designated as safety issue: No ]

    Developmental assessment at term and three month

    1. General Movements Neuromotor scale
    2. Neurological examination


Secondary Outcome Measures:
  • Developmental assessment - a composite of several measures [ Time Frame: 18 month ] [ Designated as safety issue: No ]

    Developmental assessment at 18 month

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


Estimated Enrollment: 100
Study Start Date: April 2013
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Infant Massage
 Other: Infant Massage
Infant Massage

  Eligibility

Ages Eligible for Study:   up to 4 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01779661

Contacts
Contact: Hagit Friedman, PhD 972-54-5841314 hmts@netvision.net.il
Contact: Omer Bar-Yosef, MD PhD 972-52-6667344 omerbary@gmail.com

Locations
Israel
Chaim Seba Medical Center Not yet recruiting
Ramat-Gan,, Israel, 56210
Contact: Omer Bar-Yosef, MD PhD         omerbary@gmail.com    
Contact: Caroline Barmatz, HT BPT MHA         caroline.barmatz@gmail.com]    
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            
Sponsors and Collaborators
Sheba Medical Center
University of Haifa
  More Information

No publications provided

Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01779661     History of Changes
Other Study ID Numbers: SHEBA-12-9524-OB-CTIL
Study First Received: January 27, 2013
Last Updated: March 21, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Sheba Medical Center:
Neurodevelopment, Infant-Aquatics, Prematurity

Additional relevant MeSH terms:
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 19, 2013