Summary

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 Birth Weight

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