Randomized Trial of Early Developmental Intervention on Outcomes in Children after Birth Asphyxia in Developing Countries - 25/03/13
, Shivaprasad S. Goudar, MD, MHPE 3, Omrana Pasha, MBBS, MSPH 4, Elwyn Chomba, MD 2, 5, Jan L. Wallander, PhD 6, Fred J. Biasini, PhD 1, Elizabeth M. McClure, MEd 7, Vanessa Thorsten, MPH 7, Hrishikesh Chakraborty, DrPH 7, 8, Dennis Wallace, PhD 7, Darlene L. Shearer, PhD 9, Linda L. Wright, MD 10Brain Research to Ameliorate Impaired Neurodevelopment-Home-Based Intervention Trial Committee and the National Institute of Child Health and Human Development Global Network for Women’s and Children’s Health Research Investigators
Reprint requests: Waldemar A. Carlo, MD, University of Alabama at Birmingham, 1700 6th Avenue South: 176F Suite 9380, Birmingham, AL 35233-7335.Abstract |
Objective |
To determine if early developmental intervention (EDI) improves developmental abilities in resuscitated children.
Study design |
This was a parallel group, randomized controlled trial of infants unresponsive to stimulation who received bag and mask ventilation as part of their resuscitation at birth and infants who did not require any resuscitation born in rural communities in India, Pakistan, and Zambia. Intervention infants received a parent-implemented EDI delivered with home visits by parent trainers every other week for 3 years starting the first month after birth. Parents in both intervention and control groups received health and safety counseling during home visits on the same schedule. The main outcome measure was the Mental Development Index (MDI) of the Bayley Scales of Infant Development, 2nd edition, assessed at 36 months by evaluators unaware of treatment group and resuscitation history.
Results |
MDI was higher in the EDI (102.6 ± 9.8) compared with the control resuscitated children (98.0 ± 14.6, 1-sided P = .0202), but there was no difference between groups in the nonresuscitated children (100.1 ± 10.7 vs 97.7 ± 10.4, P = .1392). The Psychomotor Development Index was higher in the EDI group for both the resuscitated (P = .0430) and nonresuscitated children (P = .0164).
Conclusions |
This trial of home-based, parent provided EDI in children resuscitated at birth provides evidence of treatment benefits on cognitive and psychomotor outcomes. MDI and Psychomotor Development Index scores of both nonresuscitated and resuscitated infants were within normal range, independent of early intervention.
Le texte complet de cet article est disponible en PDF.Keyword : ASQ, ASQ:SE, BSID-II, BSID-III, EDI, LMIC, MDI, PDI, WHO
Plan
| Funded by Eunice Kennedy Shriver National Institute of Child Health and Human Development Global Network for Women’s and Children’s Health Research and the National Institute of Neurological Disorders and Stroke (HD43464, HD42372, HD40607, and HD40636), the Fogarty International Center (TW006703), the Perinatal Health and Human Development Research Program, and the Children’s of Alabama Centennial Scholar Fund of the University of Alabama at Birmingham. W.C. is on the Mednax Board of Directors. The other authors declare no conflicts of interest. |
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| Registered at ClinicalTrials.gov: NCT00639184. |
Vol 162 - N° 4
P. 705 - avril 2013 Retour au numéro
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