Continuous Versus Bolus Feeding in Neonates With Hypoxic Ischemic Encephalopathy

NCT06447155 | Not Yet Recruiting

• 1 other identifier: IstanbulTRH-DArman-003
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoxic Ischemic Encephalopathy of Newborn; Feeding Patterns

Keywords

Newborn; Hypoxic ischemic encephalopathy; Enteral feeding; Bolus; Continuous

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Feeding intolerance

  From admission to NICU till postnatal 15th day or hospital discharge whichever came first

• Time to full enteral feeding

  From admission to NICU till postnatal 15th day or hospital discharge whichever came first

Study Arms (3)

The babies fed with bolus feeding during TH

ACTIVE COMPARATOR

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 fed with continuous feeding during TH

ACTIVE COMPARATOR

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 who were not fed

PLACEBO COMPARATOR

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

Interventions

Bolus feeding DIETARY_SUPPLEMENT

The babies fed with bolus feeding during TH composed this group

The babies fed with bolus feeding during TH

Continuous feeding DIETARY_SUPPLEMENT

The babies fed with continuous feeding during TH composed this group

The babies fed with continuous feeding during TH

Placebo DIETARY_SUPPLEMENT

The babies who were not fed during TH composed this group

The babies who were not fed

Eligibility Criteria

• Age: 0 Days - 1 Day
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

Sponsors & Collaborators

• Istanbul Training and Research Hospital: lead

Study Sites (1)

IstanbulTRH

Istanbul, Turkey (Türkiye)

Location

Related 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.

  PMID: 19797281 BACKGROUND

• 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.

  PMID: 23440789 BACKGROUND

• 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.

  PMID: 7472837 BACKGROUND

• 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.

  PMID: 36642779 BACKGROUND

• 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.

  PMID: 37014443 BACKGROUND

MeSH Terms

Conditions

Feeding Behavior; Hypoxia-Ischemia, Brain

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior; Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

DİDEM ARMAN

CONTACT

05056211989; dr_didemcaktir@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Care provider decides the type of feeding according to the randomization list which were prepared via a website (http://www.randomizer.org)
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: June 6, 2024
• Study Start: June 15, 2024
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): June 15, 2026
• Last Updated: June 6, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)