Health Condition 1: P073- Preterm [premature] newborn [other]
Conditions
Interventions
Intervention1: Early Fortification with Human Milk Fortifier (HMF): Done at feed volume of 80 mL/kg/day.1 HMF sachet will be added in 25 mL breast milk and required volume will be given every 2 hourly
Sponsors
Himalayan Institute of Medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: Preterm neonates born at gestational age 26-34 weeks and birth weight 600 g-1800 g on enteral feeds of 80mL /kg/day.
Exclusion criteria
Exclusion criteria: 1. Neonates with gross congenital anomalies. 2. Those with NEC stage 2 or worse (Modified Bell s staging) prior to enrollment. 3. Those with genetic or metabolic syndromes. 4. Those with surgical gastro-intestinal condition. 5. Those on formula feed. 6. Outborn neonates already on feed more than 80mL/kg/day. 7. More than two episodes of feed intolerance prior to enrollment. 8. Parents who don t give written informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of weight gain after regaining birth weight (g/kg/day) during NICU stay.Timepoint: At discharge | — |
Secondary
| Measure | Time frame |
|---|---|
| Linear growth (cm/week) and increase in head circumference (cm/week) during NICU stay.Timepoint: At discharge;Day of regaining birth weight.Timepoint: During NICU stay;Gross weight gain after regaining birth weight.Timepoint: At discharge;Rate of weight gain since addition of HMF.Timepoint: At discharge;Rate of weight gain from birth weight.Timepoint: At discharge;Rate of weight gain from nadir weight.Timepoint: At discharge;Total number of HMF days.Timepoint: At discharge;Incidence of extra-uterine growth restriction.Timepoint: At discharge;Incidence of necrotising enterocolitis (NEC) stage 2 or worse (Modified Bell s staging)Timepoint: At discharge;Incidence of invasive infection as determined as confirmed by positive culture of bacteria or fungus from blood, cerebrospinal fluid, urine or a normally sterile body space.Timepoint: At discharge;Duration of parenteral nutrition (PN) (days).Timepoint: At discharge;Duration of central venous line (CVL) usage (days).Timepoint: At discharge;Number of infants with retinopathy of prematurity requiring treatment, intraventricular hemorrhage, bronchopulmonary dysplasia, metabolic bone disease, anemiaTimepoint: At discharge;Duration of hospital stay (days).Timepoint: At discharge;All-cause mortalityTimepoint: At discharge;Rate of weight gain after regaining birth weight (g/kg/day), linear growth (cm/week), and increase in head circumference (cm/week)Timepoint: At 1, 3 and 6 months corrected age and at latest follow-up.;Hearing evaluation by BERA.Timepoint: Before 3 months age;Visual assessment Timepoint: At 6 months corrected age;Neurodevelopmental assessmentTimepoint: At 6 months corrected age | — |
Countries
India
Contacts
Public ContactDr Saikat Patra
Himalayan Institute of Medical Sciences
Outcome results
None listed