Clinical trial NCT06447155: Continuous Versus Bolus Feeding in Neonates With Hypoxic Ischemic Encephalopathy
Official title: The Impact of Continuous Versus Bolus Feeding in Neonates With Hypoxic Ischemic Encephalopathy Undergoing Therapeutic Hypothermia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hypoxic Ischemic Encephalopathy of Newborn
Feeding Patterns
Keywords: Newborn
Hypoxic ischemic encephalopathy
Enteral feeding
Bolus
Continuous
Lead sponsor: Istanbul Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2024-06-06
Enrollment: 60
Sex: ALL
Minimum age (years): 0
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The babies were randomized into three groups; Group 1.The neonates who received bolus feeding,Group 2. The neonates who received continuous feeding Group 3. The control group who were not fed during TH. The control group was composed of historical newborns. Three groups were compared in terms of demographic characteristics and clinical outcomes.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Therapeutic hypothermia (TH) is accepted worldwide as a standard of care for infants born at or beyond 36 weeks gestational age with moderate-to-severe hypoxic ischaemic encephalopathy (HIE).

While central nervous system is the most affected organ system , multiorgan dysfunction including renal, pulmonary, cardiac, and/or gastrointestinal (GI) compromise is not infrequent. Although the process of 'cooling' itself is well defined, based on high-quality randomized controlled trials, there are few data to inform the provision of nutrition to infants with HIE during and soon after TH.However, breastfeeding plays a beneficial role in maintaining the structural and functional integrity of the gut. It may help to reduce systemic inflammatory response and positively regulates the microbiota. In many studies it is stated that enteral feeding during TH appears to be safe and feasible. There is insufficient evidence to choose the type of enteral feeding either bolus or continuous during TH.

The present study aimed to compare the impact of different types of enteral feeding in infants with HIE receiving TH.

Detailed description: Objectives: The investigators aimed to evaluate the clinical consequences of different types of enteral nutrition during TH in babies with HIE.

Methods: This single-center, prospective randomized controlled trial (RCT) was conducted between June 2024 to June 2026 in Istanbul Research and Training Hospital. A cohort of 60 infants with HIE, born at 35 0/7 to 42 6/7 weeks of gestation who received TH were enrolled.

The infants enterally fed with bolus feeding during hypothermia (n =20), those who were fed continuously (n=20) constituted the study groups. The control group (n =20) was composed of neonates who were not fed. Infants were monitored for clinical consequences such as feeding intolerance, time to full enteral feeding, duration of hospitalization, necrotizing enterocolitis and mortality.

Eligibility criteria: Inclusion Criteria:

* The neonates with evidence of encephalopathy de¬fined by seizures or abnormalities on a modified Sarnat exam were enrolled. The hypoxic-ischemic injury was defined by 1. a pH of ≤ 7.0 and/or 2. base deficit \&amp;gt;-16 mmol/L recorded in cord blood or blood gas obtained within the first hour postnatally or a pH of 7.0 - 7.15 and/or base deficit (-10-15.9) mmol/L with the presence of an acute perinatal event (cord prolapse, placental abruption, heart rate decelerations, severe fetal bradycardia). In cases where criteria 1 or 2 are met, with the presence of seizures or a diagnosis of moderate to severe encephalopathy according to the Sarnat \&amp;amp; Sarnat classification based on neurological examination were treated with TH.

Exclusion Criteria: Infants with congenital malformation or hereditary metabolic diseases, infants whose enteral feeding was initiated before randomization and infants without lack of parental consent were excluded. The maternal and neonatal demographic characteristics and clinical outcomes were collected from medical records.

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Primary outcomes:
measure: Development of Necrotizing enterocolitis (NEC)
timeFrame: From admission to NICU till postnatal 15th day or hospital discharge whichever came first
Secondary outcomes:
measure: Feeding intolerance
timeFrame: From admission to NICU till postnatal 15th day or hospital discharge whichever came first
measure: Time to full enteral feeding
timeFrame: From admission to NICU till postnatal 15th day or hospital discharge whichever came first
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: IstanbulTRH
Study officials:
References:
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citation: Kumar J, Anne RP, Meena J, Sundaram V, Dutta S, Kumar P. To feed or not to feed during therapeutic hypothermia in asphyxiated neonates: a systematic review and meta-analysis. Eur J Pediatr. 2023 Jun;182(6):2759-2773. doi: 10.1007/s00431-023-04950-0. Epub 2023 Apr 4.