Health Condition 1: - Health Condition 2: P073- Preterm [premature] newborn [other]
Conditions
Interventions
Intervention1: Addition of hydrolysed protein powder to human milk fortifier enriched human milk: Already fortified human milk-based enteral diet using standard fortification (0.81 kcal/1 ml or 4g/100
multi-component) will be routinely supplemented with additional AA-based powdered protein fortifier (mono-component). Initially, 0.5g/day of powdered protein fortifier (one sachet of 0.5g) will be add
whichever is earlier
Intervention2: Extensively Hydrolyzed Powdered Protein Fortification on top of standard fortification: Already fortified human milk-based enteral diet using standard fortification
whichever is earlier
Control Intervention1: Standard, multi-nutrient fortification without protein enrichment Non-Fortified Protein Group: total fluid volume, volume of advancement of enteral feeds, a
Sponsors
Ompriya T P
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria All criteria must be met Preterm infants born less than 32 weeks of gestation OR birth weight less than 1500 g At least two weeks of hospital stay is expected Receiving a minimum of 100 ml kg of enteral feeds with human milk based diet either DBM or maternal breast milk fortified with multi nutrient HMF to a standard fortification 0.81 kcal 1 ml or 4 g 100 ml or 1 g sachet per 25 ml Consent obtained for parents Chronological or postnatal age greater than 7 days
Exclusion criteria
Exclusion criteria: Neonates with Major Congenital anomalies(known or diagnosed) Chromosomal abnormalities/Identifiable genetic syndrome GI surgical procedure/short bowel syndrome/ostomies NPO status: NEC/feeding intolerance/inotrope-dependent shock Potential non-viabiity and clinical instability as determined by the treating physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety endpoint is rate of feeding intolerance defined as gastric residual volume greater than 50 percent of the last feed or abdominal distension or emesis requiring withholding of feeds or interruption of feeding for more than 24 hours. Primary efficacy endpoint is rate of postnatal growth failure defined as weight for age z score decline more than 0.8 or weight gain velocity less than 75 percent of expected for postconceptional age assessed at discharge or 34 weeks PMA whichever is laterTimepoint: At Baseline and weekly interval at discharge or 34 weeks PMA | — |
Secondary
| Measure | Time frame |
|---|---|
| .Secondary outcomes (Safety) 1. Necrotizing Enterocolitis 2.Late Onset Sepsis 3.Recurrent feeding intolerance 4.BUN/Serum Creatinine 5.Time to achieve full enteral feeds 6.Time to achieve full oral feeds. Secondary outcomes (efficacy) 1. Weight gain velocity 2. Linear growth velocity 3. Head growth velocity 4. Body composition surrogates (BMI z scores, mid-arm Circumference, mid-thigh circumference) 5. Length of hospital stay Timepoint: At Baseline & weekly interval at discharge or 34 weeks PMA | — |
Countries
India
Contacts
Public ContactOmpriya T P
JAWAHARLAL NEHRU MEDICAL COLLEGE ,KLE ACADEMY OF HIGHER EDUCATION AND RESEARCH ,BELAGAVI ,KARNATAKA
Outcome results
None listed