Health Condition 1: P05-P08- Disorders of newborn related to length of gestation and fetal growth
Conditions
Interventions
None listed
Sponsors
Nestle India Limited
Eligibility
Inclusion criteria
Inclusion criteria: Stable Preterm AGA infants born between 28 to 34 weeks of gestational age who are on enteral feeding, Singleton gestation
Exclusion criteria
Exclusion criteria: • On any other clinical study affecting nutritional management during the study period • Decision to not start minimum enteral feed within 48 hours of birth • Unable to obtain informed consent from parent (s) or legal guardian prior to the initiation of enteral feeding • Infants experiencing early onset sepsis (i.e. symptoms requiring antibiotic therapy and confirmed by a positive blood culture occurring before the 3rd day of life). • Presence of clinically significant congenital heart disease • Presence of any major congenital malformations, chromosomal abnormality or major gastro intestinal disease known to affect growth • Liver failure as detected by (if laboratory data is available) aspartate aminotransferase, alanine aminotransferase, gamma-glutamyl transferase, and direct bilirubin serum values 3-fold higher than reference range. • Peri-/intra-ventricular haemorrhage (grade 3-4 in Papille classification) determined using cranial ultrasonography, if it is performed. • Other serious disorders of cardiac/ respiratory/ endocrine/ hematological/ gastrointestinal/ other systems, or serious diseases requiring surgical intervention • Reasonable potential for early transfer to a non-study institution
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| GrowthTimepoint: Observation period for each infant will be the duration of hospital stay after the initiation of first enteral feed after enrollment in to the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of Feeding intoleranceTimepoint: Observation period for each infant will be the duration of hospital stay after the initiation of first enteral feed after enrollment in to the study. | — |
Countries
India
Contacts
Public ContactDr Monjori Mitra
Medclin Research Pvt. Ltd.
Outcome results
None listed