NCT00006516

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1999

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 21, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 22, 2000

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2004

Completed
Last Updated

September 26, 2016

Status Verified

May 1, 2011

Enrollment Period

4.9 years

First QC Date

November 21, 2000

Last Update Submit

September 23, 2016

Conditions

Hypoxia, BrainHypoxia-Ischemia, Brain

Keywords

Neonatal brain injuryBrain HypoxiaCerebral HypoxiaBrain Hypoxia-IschemiaBrain Ischemia-HypoxiaCerebral Hypoxia-IschemiaCerebral Ischemia-HypoxiaEnvironmental enrichmentCognitive/sensorimotor stimulationParent-infant interactionsPrenatal hypoxia

Interventions

Infant stimulationBEHAVIORAL

Eligibility Criteria

AgeUp to 1 Month
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California at Los Angeles

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Hypoxia, BrainHypoxia-Ischemia, Brain

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesHypoxiaSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsBrain IschemiaCerebrovascular DisordersVascular DiseasesCardiovascular Diseases

Study Officials

  • Meena Garg, MD

    University of California at Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

November 21, 2000

First Posted

November 22, 2000

Study Start

September 1, 1999

Primary Completion

August 1, 2004

Last Updated

September 26, 2016

Record last verified: 2011-05

Locations

US(1)