Continuous Versus Bolus Feeding in Neonates With Hypoxic Ischemic Encephalopathy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-1
SponsorIstanbul Training and Research Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 >-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 & Sarnat classification based on neurological examination were treated with TH.
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Bolus feeding
Dietary supplementThe babies fed with bolus feeding during TH composed this group
Continuous feeding
Dietary supplementThe babies fed with continuous feeding during TH composed this group
Placebo
Dietary supplementThe babies who were not fed during TH composed this group
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: The babies fed with bolus feeding during THActive comparator 1 intervention
Group B: The babies fed with continuous feeding during THActive comparator 1 intervention
Group C: The babies who were not fedPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Development of Necrotizing enterocolitis (NEC)
The infants will be monitorized for NEC development
Time frame
From admission to NICU till postnatal 15th day or hospital discharge whichever came firstSecondary outcomes
1
Feeding intolerance
The infants will be monitorized for feeding intolerance
Time frame
From admission to NICU till postnatal 15th day or hospital discharge whichever came first2
Time to full enteral feeding
The infants will be monitorized for feeding intolerance
Time frame
From admission to NICU till postnatal 15th day or hospital discharge whichever came firstSponsors and contacts
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Source ClinicalTrials.gov
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