Multicentric, observational study to observe growth in Preterm hospitalized infants .

Not Applicable

• Conditions: Health Condition 1: P05-P08- Disorders of newborn related to length of gestation and fetal growth

• Registration Number: CTRI/2018/12/016715
• Lead Sponsor: estle India Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-08-14
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Other (Terminated)
• Sex: Not specified
• Target Recruitment: 30

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.