An interventional study of Bolus feeding and Continuous feeding in Hypoxic Ischemic Encephalopathy of Newborn and Feeding Patterns, sponsored by Istanbul Training and Research Hospital. Not yet recruiting at 1 site in Turkey. Open to participants aged 0 Days to 1 Day. Per ClinicalTrials.gov, last updated 2024-06-06.
Sponsored by Istanbul Training and Research Hospital · Not applicable, Interventional, and Supportive care
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.
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.
985 studies on the registry are indexed under Feeding Behavior; 178 are open to participants now.
This study's planned enrollment of 60 is below the median of 77 across 700 interventional studies indexed under Feeding Behavior.
Browse Feeding Behavior studies →Istanbul Training and Research Hospital is the lead sponsor of 66 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
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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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.
Dietary Supplement: Bolus feeding
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.
Dietary Supplement: Continuous feeding
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.
Dietary Supplement: Placebo
The babies fed with bolus feeding during TH composed this group
The babies fed with continuous feeding during TH composed this group
The babies who were not fed during TH composed this group
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 first
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 first
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 first
Plan to share: No — The data sets generated during and/or analyzed during current study may be available from the corresponding author on reasonable request.
Start is estimated for Jun 2024; primary completion for Jun 2026, 24 months later.
Of 503 non-industry interventional studies with no phase under Feeding Behavior, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 31. This study's planned 24 months is above that.
Counting every sponsor, half of 515 studies reached it within 14 months; a quarter within 5 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Istanbul Training and Research Hospital