Health Condition 1: P051- Newborn small for gestational age
Conditions
Interventions
Intervention1: Early fortification of breast milk: Fortification of breast milk(mothers own milk or pasteurised donor milk) with a bovine protein based fortifier(Lactodex HMF, 1g per 25ml breast milk)
Sponsors
Surya childrens medicare pvt. ltd
Seth GS Medical College and KEM Hospital
Eligibility
Inclusion criteria
Inclusion criteria: - Inborn or Out born preterm infants more than 29 weeks gestation that are: (A)Small for Gestational Age (infants with birth weight less than 10th centile for gestational age on modified Fenton’s growth chart). (B)Infants with significant Antenatal Doppler Abnormalities (Absent or Reversal of end diastolic flow in umbilical artery or Ductus venosus flow reversal)
Exclusion criteria
Exclusion criteria: 1. Infants with serious congenital anomalies that are incompatible with life 2. Infants requiring major gastrointestinal surgeries in first week of life. 3. Out born infants admitted in the unit after initiation of feeds. 4. Infants qualifying for early total enteral nutrition. 5.Infants with birth weight less than 700grams 6. Infants whose feeds could not be initiated within first 4 days of life.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulative enteral exogenous protein intake (in grams/kg/day)Timepoint: Birth to four weeks of age | — |
Secondary
| Measure | Time frame |
|---|---|
| All-cause mortalityTimepoint: Birth to discharge;Days on formula feedsTimepoint: Birth to discharge;Days on parenteral nutritionTimepoint: Birth to discharge;Duration of hospital stayTimepoint: Birth to discharge;Enteral calorie, protein & enteral feed volume intakeTimepoint: Birth to discharge;Gain in head circumference(cm/week)(Change in Z score)Timepoint: Birth to discharge;Gain in length(cm/week) during NICU stay(Change in Z score)Timepoint: Birth to discharge;Neonatal morbidities- (A)Intra ventricular hemorrhage (Grade 3 or more) according to Papile’s classification (B)Patent Ductus Arteriosus requiring treatment, (C) Apnea requiring IPPV, (D) Hypoglycemia, (E) Late onset sepsis (Blood and/or CSF culture positive after 72 hours of age), (F) Necrotizing Enterocolitis (stage 2 or higher as per Modified Bell’s staging), (G)Retinopathy of prematurity requiring intervention (laser or anti VEGF), (H)Bronchopulmonary dysplasia (according to Jensen’s criteria) (I)Periventricular Leukomalacia (J) Duration of Mechanical Ventilation (K)Anemia of prematurity ( Hemoglobin of less than 10g/dl at or beyond 4 weeks of age) (L)Metabolic Bone Disease (I) Spontaneous Intestinal Perforation Timepoint: Birth to discharge;Number of days of feed interruptionTimepoint: Birth to discharge;Time to reach full enteral feeds(160 ml/kg/day)Timepoint: Birth to discharge;Time to regain birth weightTimepoint: Birth to discharge;Weight gain during NICU stay(g/kg/day) (Change in Z score)Timepoint: Birth to discharge | — |
Countries
India
Contacts
Public ContactPrathamesh Khedkar
Surya childrens medicare pvt. ltd.
Outcome results
None listed