Pilot randomized trial of therapeutic hypothermia with serial cranial ultrasound and 18-22 month follow-up for neonatal encephalopathy in a low resource hospital setting in Uganda: study protocol
2011

Therapeutic Hypothermia for Neonatal Encephalopathy in Uganda: Study Protocol

Sample size: 36 publication Evidence: low

Author Information

Author(s): Robertson Nicola J, Hagmann Cornelia F, Acolet Dominique, Allen Elizabeth, Nyombi Natasha, Elbourne Diana, Costello Anthony, Jacobs Ian, Nakakeeto Margaret, Cowan Frances

Primary Institution: University College London

Hypothesis

Is therapeutic hypothermia safe and effective for neonatal encephalopathy in low-resource settings?

Conclusion

The pilot study suggests that therapeutic hypothermia using a low-cost method is feasible in a low-resource setting, but caution is needed due to higher mortality observed in the cooled group.

Supporting Evidence

  • Therapeutic hypothermia has been shown to increase survival with normal neurological function in high-income countries.
  • Perinatal asphyxia is significantly more common in low-resource settings compared to developed countries.
  • The study aims to assess the feasibility of a larger randomized controlled trial in Uganda.

Takeaway

This study is trying to see if cooling babies with brain injury can help them get better, especially in places where there aren't many resources.

Methodology

Infants were randomized to receive either standard care or standard care plus cooling to a target temperature of 33-34°C for 72 hours.

Potential Biases

Potential bias due to the small sample size and the inability to control for all variables in a low-resource setting.

Limitations

The study was not powered to assess efficacy or safety, and higher mortality in the cooled group raises concerns.

Participant Demographics

Infants with perinatal asphyxia admitted to the special care baby unit at Mulago Hospital.

Statistical Information

Confidence Interval

95% CI 0.7-37

Digital Object Identifier (DOI)

10.1186/1745-6215-12-138

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