A clinical trial to study the effects of a feeding method in preterm newborns with cessation of breathing and gastroesophageal reflux
- Conditions
- Health Condition 1: null- Gastroesophageal reflux associated apnea of preterm neonates
- Registration Number
- CTRI/2015/03/005656
- Lead Sponsor
- Medical College Kolkata
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 16
Inclusion criteria
(i)Intramural live births.
(ii)Gestational age less than 37 weeks.
(iii)Babies on enteral feeding (partial/complete) with human milk with recurrent apnea clinically suspected to be due to gastroesophageal reflux.
(iv)Parents or caregivers or their legally acceptable/ authorised representatives consenting to take part in the study.
Exclusion Criteria:
(i)Extramural live births
(ii)Neonates not on enteral feeds due to any reason
(iii)Neonates on invasive mechanical ventilation
(iv)Neonates with major congenital anomalies
(v)Neonates with apnea diagnosed to be due to conditions other than gastroesophageal reflux. Thus, preterm neonates with apnea diagnosed to be due to sepsis, metabolic disturbances, electrolyte imbalances, patent ductus arteriosus, intracranial hemorrhage etc will be excluded.
(vi)Parents or caregivers or their legally acceptable/ authorised representatives not consenting to take part in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method