CTRI/2018/12/016715
Other
未知
Growth and nutritional biomarkers in preterm infants in NICU â?? a Multicentric Study in India - PTF
estle India Limited0 sites30 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Health Condition 1: P05-P08- Disorders of newborn related to length of gestation and fetal growth
- Sponsor
- estle India Limited
- Enrollment
- 30
- Status
- Other
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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