Effect of early total versus gradual enteral feeding on short term outcomes in neonates less than 32 weeks of gestation
Trial Snapshot
- Phase
- Phase 3 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- The time to reach full feeds in early total enterally fed as compared to gradually fed newborns
Study Overview
Brief Summary
The present study shall be conducted in Department of Paediatrics and Department of Neonatology, Pt. B . D. Sharma, Post Graduate Institute of Medical Sciences, Rohtak. Study participants shall be taken from neonatal intensive care unit Pt B D Sharma PGIMS Rohtak. Very preterm neonates (Gestational age 28 to 31+6 weeks) who fulfil the inclusion criteria will be recruited for the study Randomisation will be done by block randomisation technique using computer generated block randomisation. The outcome would be assessed in accordance to the day of attaining full feeds in very preterm neonates(28 to 31+6 weeks) and also determine the all cause mortality between the two feeding groups. Secondarily this study aims to assess the incidence of sepsis, Necrotising enterocolitis(NEC), episodes of feed intolerance, duration of hospital stay, anthropometric indices, till discharge in preterm neonates fed enterally versus neonates fed gradually.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 0.00 Day(s) to 90.00 Day(s) (—)
- Sex
- All
Inclusion Criteria
- •Very preterm neonates with gestational age 28 to 31+6 (after taking informed parental consent) weeks fulfilling the following criterion 1.Hemo dynamically stable neonates 2.No abdominal distention.
Exclusion Criteria
- •Gestational age less than 28 weeks
- •Severe birth asphyxia
- •Major gastro intestinal congenital anomalies
- •Absence /reversed end diastolic flow in the umbilical artery on antenatal USG
- •Respiratory support beyond nasal prongs, CPAP, NIMV 6.
Outcomes
Primary Outcomes
The time to reach full feeds in early total enterally fed as compared to gradually fed newborns
Time Frame: Any time during the study period
Secondary Outcomes
- To determine the incidence of sepsis, Necrotising enterocolitis(NEC), episodes of feed intolerance, duration of hospital stay, anthropometric indices, till discharge in the two feeding groups(Any time during the study period)
Investigators
Dr N D Vaswani
Pt. B D Sharma Post Graduate Institute of Medical Sciences, Rohtak