Health Condition 1: P76-P78- Digestive system disorders of newborn
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: a) Gestational Age (GA) at birth: Intramural neonates born between 28 weeks 0 days to 32 weeks 6 days of gestational age b) Age at enrolment: Within the first 72 hours of life. c) Sick neonates initiated on full intravenous fluids d) Written informed consent obtained from the parent/legal guardian.
Exclusion criteria
Exclusion criteria: a. Major congenital gastrointestinal anomalies (e.g., oesophageal atresia, intestinal atresia, gastroschisis, omphalocele). b. Chromosomal anomalies (likeTrisomy 13, 18, 21). c. Definite NEC (stage 2 or more ) or spontaneous intestinal perforation prior to randomization. d. Features of multi organ dysfunction within first 72 hours of life ( any one of Gastro intestinal bleeding , shock requiring 2or more inotropes , acute renal failure ) e. Need for immediate surgical intervention
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to Full Enteral Feeds in daysTimepoint: Time in days of 150 ml per kg per day enteral feeding achieved and sustained for 48 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Incidence of Feeding Intolerance 2.Incidence of NEC Stage 2 OR MORE 3.Duration of iv fluid OR TPN Use 4.Length of Hospital Stay 5.Time to regain birth weight 6.Anthropometric GainsTimepoint: TILL DISCHARGE | — |
Countries
India
Contacts
IPGMER AND SSKM HOSPITAL