Home Stimulation for Brain-Asphyxiated Infants

Sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)

Overall Status

Completed

CT.gov ID

NCT00006516

Collaborator

(none)

120

Enrollment

Location

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypoxia, Brain Hypoxia-Ischemia, Brain	Behavioral: Infant stimulation	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single

Primary Purpose:

Treatment

Official Title:

Neuroplasticity of Brain-Asphyxiated Infants: Efficacy of Intervention

Study Start Date :

Sep 1, 1999

Actual Primary Completion Date :

Aug 1, 2004

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 1 Month

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria

All of the following criteria must be met:

Gestation age (GA) at birth >= 28 weeks
Discharged to home care with parent or other guardian who has legal authority to give informed consent
Greater than 10th percentile for GA at birth using the scales according to Lubchenco, Hansman, and Boyd from Pediatrics 1966 volume 37 and Battaglia and Lubchenco in the Journal of Pediatrics 1967 volume 71
Jewelry in pierced body parts can be removed
Mothers > 17 years old
Recruited within 60 days of EDC (estimated date of conception)

Two or more of the following must be met:

Intrapartum distress as determined by placental abruption, thick meconium staining of amniotic fluid, sustained fetal bradycardia of heart rate < 100 beats/min, or late or absent heart rate variability
Profound metabolic or mixed academia as determined by umbilical artery pH < 7.0, base deficit of > 10 mEq/L or pH < 7.1 and base excess greater than 14 mmol/L within 72 hours of birth, Apgar score < 5 at 5 minutes or beyond, or need for positive pressure ventilation resuscitation for > 1 min after birth
Neonatal neurological manifestations such as seizures during hospital stay, lethargy, hypotonia or hypertonia, stupor, flaccidity, or decerebration
Multiple organ system dysfunction
Abnormal EEG, CT scan, or MRI consistent with hypoxic or ischemic brain insult

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)