Impact of prophylactic continuous positive airway pressure in the delivery room (DR-CPAP) on neonates <1500g in a low-resource setting: A feasibility trial
Not Applicable
- Conditions
- Paediatrics
- Registration Number
- PACTR202208462613789
- Lead Sponsor
- Mbale Clinical Research Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
•Liveborn infants born weighing <1500g
•Infants born in Mbale RRH
•Mother who can understand English, Luganda, Ateso or Lumasaba
•Mother is willing and able to give informed, written consent for participation of her infant in the study.
•Mother aged 18 years or above, or those under 18 so long as emancipated.
Exclusion Criteria
•Infants born weighing =1500g
•Stillborn infants
•Infants born outside of Mbale RRH
•Mother who can not understand English, Luganda, Ateso or Lumasaba
•Maternal death
•Infants with major congenital abnormality e.g. gastroschisis, cyanotic heart disease
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method eonatal mortality - death before 28 days of age
- Secondary Outcome Measures
Name Time Method <br>•Total time on CPAP (days)<br>•High grade (grades III and IV) intraventricular haemorrhage on cranial ultrasound before 7 days of age<br>•Haemodynamically significant patent ductus arteriosus on echocardiogram at 72 hours of age<br>•Significant nasal septal erosions (Superfical erosion or septal necrosis) daily until CPAP is weaned<br>•Pneumothorax on lung ultrasound<br>•Bronchopulmonary dysplasia – need for supplemental oxygen for =28 days<br>•Length of hospital stay (days)<br>