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Dates
study started
estimated completion:

Description

Summary

There is uncertainty in the effect of KMC in unstable babies and there is a lack of evidence to guide how stable an infant must be to gain a mortality benefit from KMC. There is therefore, a need for a well-designed RCT that initiates KMC within 48 hours after birth to examine the effect on mortality versus conventional incubator care in infants weighing ≤2000g who are considered by the responsible clinician to be unstable. We propose such a parallel group RCT to be conducted at Jinja Hospital, a resource-limited regional referral facility in eastern Uganda.

Official Title

The OMWaNA Study: Operationalizing Kangaroo Mother Care Among Unstable Low Birth Weight Neonates in Africa: a Randomized Controlled Trial to Examine Impact on Mortality in Uganda

Keywords

Kangaroo Mother Care Incubator Care Neonates Low birth weight Unstable

Eligibility

You can join if…

  • Alive
  • Born at Jinja Hospital
  • Admitted within 48 hours after birth
  • Admitted within study period
  • Born weighing ≥700g and ≤2000g
  • Have no congenital anomalies or severe medical problems that preclude safe use of KMC
  • Mother able and willing to participate in KMC
  • Clinically unstable (defined by need for ≥2 of the following: oxygen, CPAP, IV fluids, antibiotics, anticonvulsants, jaundice requiring phototherapy)

You CAN'T join if...

  • Stillborn
  • Outborn
  • Admitted more than 48 hours after birth
  • Admitted outside study period
  • Born weighing>2000g or <700g
  • Have visually recognisable congenital malformations, suspected genetic anomalies, or other severe medical problems
  • Mother unable or unwilling to participate in KMC
  • Bradycardia (<60 bpm) for a period>5 minutes
  • Requiring bag-mask ventilation for a period>15 minutes
  • Clinically stable (defined by lack of need for ≥2 of the aforementioned criteria)
  • Jaundice not responding to conventional phototherapy

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT02811432
Study Type
Interventional
Last Updated
June 2016
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