Clinical trial NCT06344286: The Effects of Minimal Enteral Nutrition on Mesenteric Blood Flow and Oxygenation in Neonates With HIE
Official title: The Effects of Minimal Enteral Nutrition on Mesenteric Blood Flow and Oxygenation Among Neonates With Hypoxic-ischemic Encephalopathy Under Therapeutic Hypothermia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoxic-Ischemic Encephalopathy
Keywords: Therapeutic hypothermia
Minimal enteral nutrition
Mesenteric oxygenation
Mesenteric blood flow
Splanchnic oxygenation
Cerebrosplanchnic ratio
Lead sponsor: Istanbul Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2024-04-03
Enrollment: 60
Sex: ALL
Minimum age (years): 0
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: An enteral intake of breast milk with a volume of 10-20 mL/kg/day was defined as minimal enteral feeding. Minimal enteral feeding was initiated at postnatal 24 hours with breast milk via an orogastric tube. A total daily intake of 120 ml/kg/day was defined as full enteral feeding.

The babies were randomized into two groups based on whether they received MEN during TH. While the babies fed with MEN during TH constituted the study group, the control group was composed of the babies who were given the same amount of distilled water according to the same protocol. Two groups were compared in terms of demographic characteristics, clinical outcomes, NIRS and Doppler measurements.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to evaluate the effects of minimal enteral nutrition (MEN) on mesenteric blood flow and oxygenation with Doppler USG and Near Infrared Spectroscopy (NIRS) during therapeutic hypo¬thermia (TH) in babies with hypoxic ischemic encephalopathy. The main question it aims to answer is:

1- How do the mesenteric blood flow and oxygenation get affected with MEN during TH? Participants will be either fed with MEN during TH or given placebo.

Detailed description: Objectives: The investigators aimed to evaluate the effects of minimal enteral nutrition (MEN) on mesenteric blood flow and oxygenation with Doppler USG and Near Infrared Spectroscopy (NIRS) during therapeutic hypo¬thermia (TH) in babies with HIE.

Methods: This prospective, randomized controlled study was conducted between September 2020 to August 2022. The infants receiving MEN during hypothermia (n =30) and those who were not fed (n=30) constituted the study and control groups. Infants were monitored continuously with NIRS and mesenteric arterial blood flow velocities were measured with Doppler USG before and after feeding.

Eligibility criteria: 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 \&amp;gt;-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 \&amp;amp; 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.

Primary outcomes:
measure: Cerebral and mesenteric blood flow velocities and oxygenation
timeFrame: (From postnatal first day until postnatal 4 th day)Doppler US of SMA and MCA performed before feeding (15-30 minutes before) and 60 minutes after feeding
measure: Cerebral and mesenteric rSO2 values
timeFrame: (From postnatal first day until postnatal 4 th day) Recording of NIRS data was commenced 60minutes before the initiation of TH and was continued during the procedure till 24 hours after cessation of TH
Secondary outcomes:
measure: Development of NEC
timeFrame: From admission to NICU till postnatal 15th day or hospital discharge whichever came first,
measure: Feeding intolerance
timeFrame: From admission to NICU till postnatal 15th day or hospital discharge whichever came first,
measure: Time to full enteral feeding
timeFrame: From admission to NICU till postnatal 15th day or hospital discharge whichever came first,
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: IstanbulTRH
Study officials:
affiliation: Istanbul Training and Research Hospital
name: DİDEM ARMAN
role: PRINCIPAL_INVESTIGATOR
References: