GoldBamboo.com - Knowledge is strong medicine
  

Improving Brain Development in Medically Healthy Premature Infants - Article


  Not Signed In - Sign In / Register






Developmental Dyspraxia


Clinical Trial: Improving Brain Development in Medically Healthy Premature Infants

This study has been completed.

Sponsored by: National Institute of Child Health and Human Development (NICHD)
Information provided by: National Institute of Child Health and Human Development (NICHD)

Purpose

Premature infants born between 28 and 33 weeks’ gestation often have significant brain damage. Brain damage can be caused by the much greater stimulation the infant receives in the neonatal intensive care unit (NICU) as compared to the mother’s womb. This study will test the effectiveness of specialized and individualized NICU developmental care in preventing brain damage.

Condition Treatment or Intervention
Premature Birth
 Behavior: Newborn Individualized Developmental Care Assessment Program

MedlinePlus related topics:  High Risk Pregnancy

Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Active Control, Factorial Assignment, Efficacy Study

Official Title: Neurodevelopment and Experience: Behavior, Quantitative EEG and MRI

Further Study Details: 
Primary Outcomes: neurodevelopmental function; EEG; MRI
Expected Total Enrollment:  90

Study start: May 2000

From 28 to 33 weeks' gestation, significant neurological reorganization takes place, initiating fetal behavioral individuality and capacity for extrauterine survival. Infants born at this transitional stage exhibit unexpectedly significant brain dysfunction as they develop and age. The majority of these infants will develop psychomotor, cognitive, and attentional function deficits as well as emotional vulnerability and substandard school performance. Research suggests that these symptoms are due to a central deficit in frontal lobe processing of complex information. This central deficit may result from increased vulnerability of cerebral white matter during the last trimester of gestation, its phase of most rapid development. Persistent stress due to inappropriate sensory stimulation may contribute to alteration of early brain structure and function. This study will identify specific adaptations of the preterm brain to the transient NICU experience in order to estimate the potential of such experience in remodeling neuroanatomical structure and neurodevelopmental function. Further, the study will evaluate a program of specialized developmental care within the NICU environment.

The study’s specialized developmental care model views the preterm infant as a fetus and attempts to reduce the discrepancy between the technological hospital environment and the mother’s womb. A developmental specialist team will support the NICU caregivers. The developmental specialists will observe the infant’s behavior and use these observations to formulate descriptive neurobehavioral reports and suggestions, to structure caregiving procedures in coordination with the infant’s sleep/wake cycle, and to maintain the infant’s well-regulated behavioral balance. The goal of the intervention is to promote the infant’s strengths while reducing the infant’s self-regulatory vulnerability.

Sixty medically healthy infants born between 28 and 33 weeks’ gestation will be randomly assigned to standard NICU care or specialized developmental care. Preterm infants will be compared to 30 healthy full term infants. All infants will be assessed at 42 weeks' postconceptional age in three neurodevelopmental domains: neurobehavioral function, neuroelectrophysiological function, and neuroanatomic structure. Assessments will focus on distinct regions of the brain (occipital and frontal lobes) and the corpus callosum (which connects the right and left sides of the brain).

Eligibility

Ages Eligible for Study:  28 Weeks   -   33 Weeks,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria for Preterm Infants

  • Born at Brigham and Women's Hospital (BWH), Boston
  • Family residence in the greater Boston area
  • Gestational age at birth of 28 to 33 weeks assessed by mother's dates, the Ballard assessment, and prenatal ultrasound as available
  • Birthweight, height, and head circumference appropriate (10th to 90th percentile) for gestational age
  • 1 and 5 minute Apgar >= 7
  • Endotracheal intubation and mechanical ventilator support, including continuous positive airway pressure (CPAP), for < 48 hours after delivery
  • Normal cranial ultrasound(s) within first 7 days of life
  • Mother between 15 and 39 years old
  • Telephone access
  • Sufficient English language facility to assure successful communication and follow-up

Exclusion Criteria for Preterm Infants

  • Use of dopamine or hydrocortisone
  • Chromosomal or congenital abnormalities (e.g., Down's, Turner's, Klinefelter's syndromes)
  • Congenital or acquired infections (e.g., TORCH, HIV, sepsis)
  • Major maternal illness; diagnosed mental and/or emotional impairment; reported alcohol, nicotine, or illegal drug use and/or positive urine toxicity screen; or chronic medication treatment (e.g., synthroid, insulin, steroids)

Location Information


Massachusetts
      Children's Hospital Boston, Boston,  Massachusetts,  02115,  United States

Study chairs or principal investigators

Heidelise Als, PhD,  Principal Investigator,  Harvard University   

More Information

Publications

Als H, Duffy FH, McAnulty GB, Rivkin MJ, Vajapeyam S, Mulkern RV, Warfield SK, Huppi PS, Butler SC, Conneman N, Fischer C, Eichenwald EC. Early experience alters brain function and structure. Pediatrics. 2004 Apr;113(4):846-57.

Rivkin MJ, Wolraich D, Als H, McAnulty G, Butler S, Conneman N, Fischer C, Vajapeyam S, Robertson RL, Mulkern RV. Prolonged T*2 values in newborn versus adult brain: Implications for fMRI studies of newborns. Magn Reson Med. 2004 Jun;51(6):1287-91.

Study ID Numbers:  R01HD38261
Record last reviewed:  October 2004
Last Updated:  October 19, 2004
Record first received:  July 21, 2003
ClinicalTrials.gov Identifier:  NCT00065364
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


Take control over your directory listings...INSTANTLY

Every day, thousands of users find businesses like yours in the GoldBamboo directory.

Limited Time Offer!!!

For only $50 a year, a savings of 50% off our standard rate:

  • Edit your listing (whenever you want!)
  • Link to your website
  • Choose which categories you are listed in
  • Describe your services

The process will take only a few minutes and consists of 3 easy steps:

1. Register     >     2. Edit Listings     >     3. Publish

Your Company
your street
yourtown, YS 12345
888-888-8888



No Thanks

Popular Treatments

Acne Treatment ADHD Treatment Allergy Treatment Alzheimer's Treatment
Anemia Treatment Arthritis Treatment Asthma Treatment Bipolar Disorder Treatment
Bird Flu Treatment Bladder Cancer Treatment Bladder Control Treatment Blood Pressure Treatment
Brain Tumor Treatment Breast Cancer Treatment Bronchitis Treatment Cancer Treatment
Cancer Alternative Treatment Cataract Treatment Cirrhosis Treatment Colitis Treatment
Colon Cancer Treatment Common Cold Treatment Conjunctivitis Treatment Constipation Treatment
Crohn's Disease Treatment Cystic Fibrosis Treatment Depression Treatment Dermatitis Treatment
Diabetes Treatment Edema Treatment Epilepsy Treatment Erectile Dysfunction Treatment
Fibromyalgia Treatment GERD Treatment Glaucoma Treatment Gout Treatment
Hay Fever Treatment Headache Treatment Heart Disease Treatment Hepatitis Treatment
High Blood Pressure Treatment High Cholesterol Treatment Hives Treatment Hypertension Treatment
Hypoglycemia Treatment IBS Treatment Impotence Treatment Indigestion Treatment
Infertility Treatment Influenza Treatment Insomnia Treatment Lactose Intolerance Treatment
Leukemia Treatment Lung Cancer Treatment Lyme Disease Treatment Macular Degeneration Treatment
Menopause Treatment Migraine Treatment Osteoarthritis Treatment Osteoporosis Treatment
Pancreatic Cancer Treatment PMS Treatment Pneumonia Treatment Prostate Diseases Treatment
Restless Leg Treatment Rheumatoid Arthritis Treatment Sepsis Treatment Sinusitis Treatment
Skin Cancer Treatment Sleep Apnea Treatment Snoring Treatment Stroke Treatment
Testicular Cancer Treatment
GoldBambooTM

Your Integrative Health and Wellness Resource for Developmental Dyspraxia.

September 7, 2008



Page Updated: September 6, 2005
Disclaimer: All material displayed on the GoldBamboo.com website is provided for educational purposes only. Consult a physician regarding the applicability of any information found on GoldBamboo.com to your symptoms or medical condition.

Insurance Quotes | Home | About Us | Link To Us | Feedback | Disclaimer | Privacy Policy | Terms of Use | Google Co-op | Health Forums

Copyright © 2004-2008 - Gold Bamboo LLC
All rights reserved.

HONcode accreditation seal.

We comply with the HONcode standard for health trust worthy information:
verify here.