Hypoxic Ischemic Encephalopathy of Newborn, Feeding Patterns
Conditions
Keywords
Newborn, Hypoxic ischemic encephalopathy, Enteral feeding, Bolus, Continuous
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.
Interventions
DIETARY_SUPPLEMENTBolus feeding
The babies fed with bolus feeding during TH composed this group
DIETARY_SUPPLEMENTContinuous feeding
The babies fed with continuous feeding during TH composed this group
DIETARY_SUPPLEMENTPlacebo
The babies who were not fed during TH composed this group
Sponsors
Istanbul Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Masking description
Care provider decides the type of feeding according to the randomization list which were prepared via a website (http://www.randomizer.org)
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.
Eligibility
Sex/Gender
ALL
Age
0 Days to 1 Days
Healthy volunteers
No
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 >-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.
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. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Development of Necrotizing enterocolitis (NEC) | From admission to NICU till postnatal 15th day or hospital discharge whichever came first | The infants will be monitorized for NEC development |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feeding intolerance | From admission to NICU till postnatal 15th day or hospital discharge whichever came first | The infants will be monitorized for feeding intolerance |
| Time to full enteral feeding | From admission to NICU till postnatal 15th day or hospital discharge whichever came first | The infants will be monitorized for feeding intolerance |
Countries
Turkey (Türkiye)
Contacts
Primary ContactDİDEM ARMAN
Outcome results
None listed