Infant Aquatics Neurodevelopment Premature Infants (IA-NPI)

This study is currently recruiting participants.
Verified February 2014 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: February 12, 2014
Last verified: February 2014

January 27, 2013
February 12, 2014
April 2013
August 2015   (final data collection date for primary outcome measure)
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
Developmental assessment [ Time Frame: 3 month ] [ Designated as safety issue: No ]

Developmental assessment at term and three month

  1. General Movements Neuromotor scale
  2. Neurological examination
Complete list of historical versions of study NCT01779661 on ClinicalTrials.gov Archive Site
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
Developmental assessment [ Time Frame: 18 month ] [ Designated as safety issue: No ]

Developmental assessment at 18 month

  1. IMP neuromotor developmental scale
  2. Griffith mental development scale
Not Provided
Not Provided
 
Infant Aquatics Neurodevelopment Premature Infants
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Cerebral Palsy
  • Preterm Birth
  • Development
  • 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
  • Other: Infant Massage
    Infant Massage
  • Active Comparator: Infant Aquatics
    Intervention: Other: Infant Aquatics
  • Active Comparator: Infant Massage
    Infant Massage
    Intervention: Other: Infant Massage
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
Not Provided
August 2015   (final data collection date for primary outcome measure)

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.

Both
up to 4 Weeks
Yes
Contact: Hagit Friedman, PhD 972-54-5841314 hmts@netvision.net.il
Contact: Omer Bar-Yosef, MD PhD 972-52-6667344 omerbary@gmail.com
Israel
 
NCT01779661
SHEBA-12-9524-OB-CTIL
No
Sheba Medical Center
Sheba Medical Center
University of Haifa
Not Provided
Sheba Medical Center
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP