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Medical Clowning in the NICU (Neonatal Intensive Care Unit and Their Effects on Parents and Staff (clowns)

B

Baruch Padeh Medical Center

Status

Unknown

Conditions

Premature Neonate

Study type

Observational

Funder types

Other

Identifiers

NCT02048202
38-2013.CTIL

Details and patient eligibility

About

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.

Full description

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.

Enrollment

60 estimated patients

Sex

All

Ages

Under 4 weeks old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • neonates wherein their parents have expressed consent to participate in trail
  • neonates with parents who are able to understand and fill in questioners
  • neonates with no chromosomal deficiencies and no genetic deficiency

Exclusion criteria

  • neonates with parents who are unable to understand and fill in questioners
  • neonates with intraventricular bleeding IVH/PVH
  • neonates with periventricular hemorrhage
  • neonates with known chromosomal deficiencies or genetic deficiency

Trial design

60 participants in 1 patient group

premature neonate
Description:
premature neonate

Trial contacts and locations

1

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Central trial contact

Shay Barak, MD; Hagit Friedman, PhD

Data sourced from clinicaltrials.gov

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