Infant Aquatics Neurodevelopment Premature Infants
IA-NPI
The Effect of Infant Aquatics for Neurodevelopment of Premature Infants
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 27, 2013
CompletedFirst Posted
Study publicly available on registry
January 30, 2013
CompletedStudy Start
First participant enrolled
April 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedFebruary 13, 2014
February 1, 2014
2.3 years
January 27, 2013
February 12, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Developmental assessment - a composite of several measures
Developmental assessment at term and three month 1. General Movements Neuromotor scale 2. Neurological examination
3 month
Secondary Outcomes (1)
Developmental assessment - a composite of several measures
18 month
Study Arms (2)
Infant Aquatics
ACTIVE COMPARATORInfant Massage
ACTIVE COMPARATORInfant Massage
Interventions
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
Eligibility Criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sheba Medical Centerlead
- University of Haifacollaborator
Study Sites (1)
Chaim Seba Medical Center
Ramat Gan, 56210, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 27, 2013
First Posted
January 30, 2013
Study Start
April 1, 2013
Primary Completion
August 1, 2015
Last Updated
February 13, 2014
Record last verified: 2014-02