Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO

The significant improvements in neonatal intensive care over the past decades have led to a substantial

reduction in neonatal mortality but, on the other hand, have increased the survival of sick neonates who

are at high risk of significant multi-system complications and are likely to remain in an unstable clinical

condition for prolonged periods. This has significant effects on the feeding pattern and feed acceptance

in the neonate.

NEC is one of the most devastating diseases in neonates, affecting around 5-10% of preterm neonates

with a birth weight below 1500 g or neonates with higher risk of compromised gut flow as stated in an

Indian report with mortality being as high as 25%  Feeding intolerance is a symptom that often precedes

the diagnosis of NEC, hence it is important to diagnose the signs and symptoms earlier. Feeding

intolerance has been defined as “the withholding of enteral feeding for > 24 hours, due to the presence of

atleast two of the following signs: “abdominal distension, absent bowel sounds, persistent significant

gastric residual, GR volume >2 mL/kg of body weight or greater than half the volume of the previous

feed, bilious or bloody GR, and/or bloody stools” 

Hence, the simultaneous technological advances in medical physics and biomedical engineering have

been directed towards the development of new monitoring techniques aimed at assessing physiological

functions and identifying their deterioration. 

NIRS is one such advancement. It has enabled the researchers to assess regional splanchnic circulation

(rSO2). Another frequently used measurement derived from rSO2 is the FTOE which compares

splanchnic oxygenation to systemic oxygenation as measured by pulse oximetry.

Considerable research related to splanchnic oxygenation has been focused around transfusion associated

necrotizing enterocolitis and anemia. Many studies have found an association between transfusions, and

overall low splanchnic oxygenation readings with intermittent increases post transfusion associated with

enteral feeding. However, there is lack of evidence regarding NIRS based intervention in enteral feeding.

This study aims at intervening enteral feeding in neonates based on normative data of rSO2 established

in studies done using NIRS as compared to the clinical judgement of enteral feeding and to further

analyse if outcome in the intervention group aids in improving care and reducing the morbidity and

mortality.