NIRS vs Clinical judgement based enteral feeding in high risk neonates- A Randomised Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- To evaluate if NIRS based (rSO2/FTOE) monitoring would predict feed intolerance
研究概览
简要总结
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 stoolsâ€
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 1.00 Day(s) 至 30.00 Day(s)(—)
- 性别
- All
入选标准
- •Neonates between 26 weeks to 40 weeks of gestation with expected compromised splanchnic perfusion admitted in NICU.
排除标准
- •Infant related: Ascites, Intraabdominal tumor, UAC in situ or No consent from parents Machine related: Severe Jaundice, Lethal Congenital anomaly, Anasarca, Hydrops, disorders of non keratinized skin.
结局指标
主要结局
To evaluate if NIRS based (rSO2/FTOE) monitoring would predict feed intolerance
时间窗: From onset of feeds (20ml/kg) upto 100ml/kg of feed volume
episodes in high risk neonates earlier as compared to clinical assessment and monitoring
时间窗: From onset of feeds (20ml/kg) upto 100ml/kg of feed volume
during enteral feeding.
时间窗: From onset of feeds (20ml/kg) upto 100ml/kg of feed volume
次要结局
- To assess(1. Time taken to achieve full feeds in both the groups)
研究者
Dr Swati Iyer
Kanchi Kamakoti CHILDS Trust Hospital
