Infant Aquatics Neurodevelopment Premature Infants

Cerebral Palsy Clinical Trial

— IA-NPI  

Official title:

The Effect of Infant Aquatics for Neurodevelopment of Premature Infants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01779661
• Other study ID #: SHEBA-12-9524-OB-CTIL
• Status: Recruiting
• Phase: N/A
• First received: January 27, 2013
• Last updated: February 12, 2014
• Start date: April 2013

Study information

• Verified date: February 2014
• Source: Sheba Medical Center
• Contact: Hagit Friedman, PhD
• Phone: 972-54-5841314
• Email: hmts[@]netvision.net.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 4 Weeks

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Palsy
• Development
• Premature Birth
• Preterm Birth

Intervention

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
• Infant Massage
Infant Massage

Locations

Country	Name	City	State
Israel	Chaim Seba Medical Center	Ramat-Gan,

Sponsors (2)

Lead Sponsor	Collaborator
Sheba Medical Center	University of Haifa

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Developmental assessment - a composite of several measures	Developmental assessment at term and three month; General Movements Neuromotor scale; Neurological examination	3 month	No
Secondary	Developmental assessment - a composite of several measures	Developmental assessment at 18 month; IMP neuromotor developmental scale; Griffith mental development scale; Vineland adaptive behavior scale	18 month	No