Continuous Versus Bolus Feeding in Neonates With Hypoxic Ischemic Encephalopathy

Feeding Patterns Clinical Trial

Official title:

The Impact of Continuous Versus Bolus Feeding in Neonates With Hypoxic Ischemic Encephalopathy Undergoing Therapeutic Hypothermia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06447155
• Other study ID #: IstanbulTRH-DArman-003
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 15, 2024
• Est. completion date: June 15, 2026

Study information

• Verified date: June 2024
• Source: Istanbul Training and Research Hospital
• Contact: DIDEM ARMAN
• Phone: 05056211989
• Email: dr_didemcaktir[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: June 15, 2026
• Est. primary completion date: June 15, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Days to 1 Day

Eligibility

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.

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Related Conditions & MeSH terms

• Brain Diseases
• Brain Ischemia
• Feeding Patterns
• Hypoxia
• Hypoxia-Ischemia, Brain
• Ischemia

Intervention

Dietary Supplement:
• Bolus feeding
The babies fed with bolus feeding during TH composed this group
• Continuous feeding
The babies fed with continuous feeding during TH composed this group
• Placebo
The babies who were not fed during TH composed this group

Locations

Country	Name	City	State
Turkey	IstanbulTRH	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

Azzopardi DV, Strohm B, Edwards AD, Dyet L, Halliday HL, Juszczak E, Kapellou O, Levene M, Marlow N, Porter E, Thoresen M, Whitelaw A, Brocklehurst P; TOBY Study Group. Moderate hypothermia to treat perinatal asphyxial encephalopathy. N Engl J Med. 2009 Oct 1;361(14):1349-58. doi: 10.1056/NEJMoa0900854. Erratum In: N Engl J Med. 2010 Mar 18;362(11):1056. — View Citation

Jacobs SE, Berg M, Hunt R, Tarnow-Mordi WO, Inder TE, Davis PG. Cooling for newborns with hypoxic ischaemic encephalopathy. Cochrane Database Syst Rev. 2013 Jan 31;2013(1):CD003311. doi: 10.1002/14651858.CD003311.pub3. — View 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. — View Citation

Martin-Ancel A, Garcia-Alix A, Gaya F, Cabanas F, Burgueros M, Quero J. Multiple organ involvement in perinatal asphyxia. J Pediatr. 1995 Nov;127(5):786-93. doi: 10.1016/s0022-3476(95)70174-5. — View Citation

Sharma S, Kallesh A, Aradhya AS, Diggikar S, Veeraiah PS, Subbareddy NN, Walikar S, Reddy IV, Sarji D, Venkatagiri P. Feasibility of Minimal Enteral Nutrition During Therapeutic Hypothermia for Perinatal Asphyxia: A Five-Year Multicenter Experience from South India. Indian J Pediatr. 2023 May;90(5):513-515. doi: 10.1007/s12098-022-04456-x. Epub 2023 Jan 16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of Necrotizing enterocolitis (NEC)	The infants will be monitorized for NEC development	From admission to NICU till postnatal 15th day or hospital discharge whichever came first
Secondary	Feeding intolerance	The infants will be monitorized for feeding intolerance	From admission to NICU till postnatal 15th day or hospital discharge whichever came first
Secondary	Time to full enteral feeding	The infants will be monitorized for feeding intolerance	From admission to NICU till postnatal 15th day or hospital discharge whichever came first