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Infant Aquatics Neurodevelopment Premature Infants (IA-NPI)

Primary Purpose

Cerebral Palsy, Preterm Birth, Development

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Infant Aquatics
Infant Massage
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring Neurodevelopment, Infant-Aquatics, Prematurity

Eligibility Criteria

1 Week - 4 Weeks (Child)All SexesAccepts 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.

Sites / Locations

  • Chaim Seba Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Infant Aquatics

Infant Massage

Arm Description

Infant Massage

Outcomes

Primary Outcome Measures

Developmental assessment - a composite of several measures
Developmental assessment at term and three month General Movements Neuromotor scale Neurological examination

Secondary Outcome Measures

Developmental assessment - a composite of several measures
Developmental assessment at 18 month IMP neuromotor developmental scale Griffith mental development scale Vineland adaptive behavior scale

Full Information

First Posted
January 27, 2013
Last Updated
February 12, 2014
Sponsor
Sheba Medical Center
Collaborators
University of Haifa
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1. Study Identification

Unique Protocol Identification Number
NCT01779661
Brief Title
Infant Aquatics Neurodevelopment Premature Infants
Acronym
IA-NPI
Official Title
The Effect of Infant Aquatics for Neurodevelopment of Premature Infants
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Unknown status
Study Start Date
April 2013 (undefined)
Primary Completion Date
August 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheba Medical Center
Collaborators
University of Haifa

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Preterm Birth, Development
Keywords
Neurodevelopment, Infant-Aquatics, Prematurity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Infant Aquatics
Arm Type
Active Comparator
Arm Title
Infant Massage
Arm Type
Active Comparator
Arm Description
Infant Massage
Intervention Type
Other
Intervention Name(s)
Infant Aquatics
Intervention Description
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
Intervention Name(s)
Infant Massage
Intervention Description
Infant Massage
Primary Outcome Measure Information:
Title
Developmental assessment - a composite of several measures
Description
Developmental assessment at term and three month General Movements Neuromotor scale Neurological examination
Time Frame
3 month
Secondary Outcome Measure Information:
Title
Developmental assessment - a composite of several measures
Description
Developmental assessment at 18 month IMP neuromotor developmental scale Griffith mental development scale Vineland adaptive behavior scale
Time Frame
18 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Week
Maximum Age & Unit of Time
4 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hagit Friedman, PhD
Phone
972-54-5841314
Email
hmts@netvision.net.il
First Name & Middle Initial & Last Name or Official Title & Degree
Omer Bar-Yosef, MD PhD
Phone
972-52-6667344
Email
omerbary@gmail.com
Facility Information:
Facility Name
Chaim Seba Medical Center
City
Ramat-Gan,
ZIP/Postal Code
56210
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Omer Bar-Yosef, MD PhD
Email
omerbary@gmail.com
First Name & Middle Initial & Last Name & Degree
Caroline Barmatz, HT BPT MHA
Email
caroline.barmatz@gmail.com]
First Name & Middle Initial & Last Name & Degree
Hagit Friedman, PhD
First Name & Middle Initial & Last Name & Degree
Omer Bar-Yosef, MD PhD
First Name & Middle Initial & Last Name & Degree
Caroline Barmatz, HT.BPT.MHA
First Name & Middle Initial & Last Name & Degree
Iris Morag, MD
First Name & Middle Initial & Last Name & Degree
Anat Lazits-Dor, BPT
First Name & Middle Initial & Last Name & Degree
Keren Mekadesh, RN BA
First Name & Middle Initial & Last Name & Degree
Zipora Strauss, MD

12. IPD Sharing Statement

Learn more about this trial

Infant Aquatics Neurodevelopment Premature Infants

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