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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
60
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.
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.
IstanbulTRH
Istanbul, Turkey (Türkiye)
Cerebral and mesenteric blood flow velocities and oxygenation
Cerebral and mesenteric blood flow velocities with Doppler US
Time frame: (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
Cerebral and mesenteric rSO2 values
Cerebral and mesenteric rSO2 values with NIRS
Time frame: (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
Development of 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 the time to full enteral feeding.
Time frame: From admission to NICU till postnatal 15th day or hospital discharge whichever came first,
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