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Home Stimulation for Brain-Asphyxiated Infants

Primary Purpose

Hypoxia, Brain, Hypoxia-Ischemia, Brain

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Infant stimulation
Sponsored by
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypoxia, Brain focused on measuring 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

Eligibility Criteria

undefined - 1 Month (Child)All SexesDoes not accept 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)

Sites / Locations

  • University of California at Los Angeles

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 21, 2000
Last Updated
September 23, 2016
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT00006516
Brief Title
Home Stimulation for Brain-Asphyxiated Infants
Official Title
Neuroplasticity of Brain-Asphyxiated Infants: Efficacy of Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
September 1999 (undefined)
Primary Completion Date
August 2004 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxia, Brain, Hypoxia-Ischemia, Brain
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Infant stimulation

10. Eligibility

Sex
All
Maximum Age & Unit of Time
1 Month
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meena Garg, MD
Organizational Affiliation
University of California at Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California at Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

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Home Stimulation for Brain-Asphyxiated Infants

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