Hypoxic-Ischemic Encephalopathy
Conditions
Keywords
Therapeutic hypothermia, Minimal enteral nutrition, Mesenteric oxygenation, Mesenteric blood flow, Splanchnic oxygenation, Cerebrosplanchnic ratio
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.
Interventions
DIETARY_SUPPLEMENTMinimal enteral nutrition
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.
DIETARY_SUPPLEMENTDistilled water
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.
Sponsors
Istanbul Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
The feeding materials were prepared inside an opaque syringe and serially numbered by Total Parenteral Nutrition Department in our institution. The investigators who made all measurements, examinations and collected data, and the nurses of the babies were blinded. All of the infants in the study group were fed with breast milk during the trial.
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.
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 |
|---|---|---|
| Cerebral and mesenteric blood flow velocities and oxygenation | (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 blood flow velocities with Doppler US |
| Cerebral and mesenteric rSO2 values | (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 | Cerebral and mesenteric rSO2 values with NIRS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 the time to full enteral feeding. |
| Development of NEC | From admission to NICU till postnatal 15th day or hospital discharge whichever came first, | The infants will be monitorized for NEC development |
| Feeding intolerance | 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)
Outcome results
None listed