Home Stimulation for Brain-Asphyxiated Infants

This study has been withdrawn prior to enrollment.
(Study terminated/withdrawn)
Sponsor:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00006516
First received: November 21, 2000
Last updated: May 20, 2011
Last verified: May 2011
  Purpose

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 Intervention Phase
Hypoxia, Brain
Hypoxia-Ischemia, Brain
Behavioral: Infant stimulation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Neuroplasticity of Brain-Asphyxiated Infants: Efficacy of Intervention

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Estimated Enrollment: 120
Study Start Date: September 1999
Estimated Study Completion Date: August 2004
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.

  Eligibility

Ages Eligible for Study:   up to 1 Month
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006516

Locations
United States, California
University of California at Los Angeles
Los Angeles, California, United States, 90095
Sponsors and Collaborators
Investigators
Principal Investigator: Meena Garg, MD University of California at Los Angeles
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00006516     History of Changes
Other Study ID Numbers: NICHD-0115, 1R01 HD38600-01
Study First Received: November 21, 2000
Last Updated: May 20, 2011
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Neonatal brain injury
Brain Hypoxia
Cerebral Hypoxia
Brain Hypoxia-Ischemia
Brain Ischemia-Hypoxia
Cerebral Hypoxia-Ischemia
Cerebral Ischemia-Hypoxia
Environmental enrichment
Cognitive/sensorimotor stimulation
Parent-infant interactions
Prenatal hypoxia

Additional relevant MeSH terms:
Brain Ischemia
Hypoxia, Brain
Hypoxia-Ischemia, Brain
Ischemia
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on October 22, 2014