Skip to content

Infant Aquatics Neurodevelopment Premature Infants

The Effect of Infant Aquatics for Neurodevelopment of Premature Infants

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01779661
Acronym
IA-NPI
Enrollment
100
Registered
2013-01-30
Start date
2013-04-30
Completion date
Unknown
Last updated
2014-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Palsy, Preterm Birth, Development

Keywords

Neurodevelopment, Infant-Aquatics, Prematurity

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.

Interventions

OTHERInfant 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

Sponsors

University of Haifa
CollaboratorOTHER
Sheba Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Weeks to 4 Weeks
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Developmental assessment - a composite of several measures3 monthDevelopmental assessment at term and three month 1. General Movements Neuromotor scale 2. Neurological examination

Secondary

MeasureTime frameDescription
Developmental assessment - a composite of several measures18 monthDevelopmental assessment at 18 month 1. IMP neuromotor developmental scale 2. Griffith mental development scale 3. Vineland adaptive behavior scale

Countries

Israel

Contacts

Primary ContactHagit Friedman, PhD
hmts@netvision.net.il972-54-5841314
Backup ContactOmer Bar-Yosef, MD PhD
omerbary@gmail.com972-52-6667344

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026