Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial

Neurodevelopmental outcomes in infants requiring resuscitation in developing countries

Waldemar A Carlo et al. J Pediatr. 2012 May.

Abstract

Objective: To determine whether resuscitation of infants who failed to develop effective breathing at birth increases survivors with neurodevelopmental impairment.

Study design: Infants unresponsive to stimulation who received bag and mask ventilation at birth in a resuscitation trial and infants who did not require any resuscitation were randomized to early neurodevelopmental intervention or control groups. Infants were examined by trained neurodevelopmental evaluators masked to both their resuscitation history and intervention group. The 12-month neurodevelopmental outcome data for both resuscitated and non-resuscitated infants randomized to the control groups are reported.

Results: The study provided no evidence of a difference between the resuscitated infants (n = 86) and the non-resuscitated infants (n = 115) in the percentage of infants at 12 months with a Mental Developmental Index <85 on the Bayley Scales of Infant Development-II (primary outcome; 18% versus 12%; P = .22) and in other neurodevelopmental outcomes.

Conclusions: Most infants who received resuscitation with bag and mask ventilation at birth have 12-month neurodevelopmental outcomes in the reference range. Longer follow-up is needed because of increased risk for neurodevelopmental impairments.

Trial registration: ClinicalTrials.gov NCT00639184.

PubMed Disclaimer

Conflict of interest statement

The authors declare no conflicts of interest.

Figures

Figure 1
Figure 1
Screening and randomization flow chart. Only control infants are reported in this study.
See this image and copyright information in PMC

References

    1. Lawn JE, Cousens S, Zupan J. 4 million neonatal deaths: When? Where? Why? Lancet. 2005;365:891–900. - PubMed
    1. Halloran DR, McClure E, Chakraborty H, Chomba E, Wright LL, Carlo WA. Birth asphyxia survivors in a developing country. J Perinatol. 2009;29:243–249. - PMC - PubMed
    1. Al-Macki N, Miller SP, Hall N, Shevell M. The spectrum of abnormal neurologic outcomes subsequent to term intrapartum asphyxia. Pediatr Neurol. 2009;41:399–405. - PubMed
    1. Perlman JM, Risser R. Cardiopulmonary resuscitation in the delivery room. Associated clinical events. Arch Pediatr Adolesc Med. 1995;149:20–25. - PubMed
    1. Singhal N, McMillan DD, Yee WH, Akierman AR, Yee YJ. Evaluation of the effectiveness of the standardized neonatal resusitation program. J Perinatol. 2001;21:388–392. - PubMed

Publication types

MeSH terms

Associated data