Home Stimulation for Brain-Asphyxiated Infants

Phase 2

Completed

• Conditions: Hypoxia, Brain; Hypoxia-Ischemia, Brain

• Registration Number: NCT00006516
• Lead Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Brief Summary

This study examines the potential benefits of a home stimulation program to treat infants who have suffered from brain asphyxiation (lack of oxygen). The program involves one year of stimulatory activities. Progress will be evaluated through neurological and behavioral exams.

Detailed Description

Although the incidence of brain injury in infants is only 2 to 5 per 1000 births, the legal and medical costs, the developmental delays, and the impact on the family are profound. Twenty to 30% of survivors of brain injury have some long-term neurologic sequelae.

This randomized controlled trial will enroll 120 term and near-term neonates with a history of asphyxia to 1-year of a standard follow-up program (provided by the Los Angeles Regional Centers) or a home-based intervention program (Utah State University's Developmental Curriculum and Monitoring System, CAMS). The experimental intervention will include individualized cognitive/neuromotor stimulation given by the child's parents under the guidance of public health nurses. Following the intervention, measures will be used to determine functional capacity (Bayley II scale and neurologic examination), behavioral outcomes (HOME and NCAST by developmental specialists), and maternal outcomes (including parent-infant interaction and perceived stress). Infants will be assessed after the 1-year intervention by psychologists and physicians masked to the intervention. Functional MRI brain studies will be conducted at discharge and 18 months of age at UCLA to assess qualitative and quantitative sensorimotor representation. Secondary outcomes include care stress and social support as reported by parents, and demographics and medical factors obtained from the hospital records.

Study Timeline

• Study Start: 1999-09
• Study First Submitted: 2000-11-21
• Study First Submitted QC: 2000-11-21
• Study First Posted: 2000-11-22
• Primary Completion: 2004-08
• Status Verified: 2011-05
• Last Update Submitted: 2016-09-23
• Last Update Posted: 2016-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

• Infants of substance abusing mothers (ISAM)
• Intrauterine growth retardation (IUGR)
• Infants requiring extracorporeal membrane oxygenation (ECMO) in the neonatal period
• Hearing or visual impairment
• Congenital cyanotic heart disease with cyanosis and requiring PGE infusion. Children with minimum cardiac structural anomalies (e.g., PDA or VSD or peripheral pulmonary stenosis) will not be excluded from the study.
• Congenital abnormalities of the central nervous system such as congenital hydrocephalus
• Grade IV intraventicular hemorrhage requiring ventriculo-peritoneal shunt (VP shunt)
• Trisomy 13, 18, or 21, or Fragile X
• Metabolic encephalopathy from inborn errors of metabolism (e.g. PKU, OTC)
• Metal or wire mesh implants, pacemaker implants, cochlear implants, orthopedic surgical wires or implants
• Status epilepticus
• Ventilator dependent at discharge
• Infectious meningitis
• Encephalitis with radiological evidence of severe cortical or severe hemispheric destruction
• Silastic catheters, broviacs, or Hickman port home TPA
• Infants who may not be available for the duration of the study
• Any infant who in the opinion of investigator has no potential to benefit from the intervention (e.g., children with prenatal herpes meningitis, severe cortical destruction, mother does not follow up with the intervention or with the follow-up appointments)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (1)

University of California at Los Angeles; 🇺🇸 Los Angeles, California, United States