Hypoxic-Ischemic EncephalopathyNCT06344286
The Effects of Minimal Enteral Nutrition on Mesenteric Blood Flow and Oxygenation in Neonates With HIE
A study testing Minimal enteral nutrition and Distilled water in people with Hypoxic-Ischemic Encephalopathy, run by Istanbul Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 0 days to 1 day
- Conditions the study is for
- Hypoxic-Ischemic Encephalopathy
- What is being tested?
- Minimal enteral nutrition and Distilled water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2020to 31 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days to 1 day
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Minimal Enteral Nutrition on Mesenteric Blood Flow and Oxygenation Among Neonates With Hypoxic-ischemic Encephalopathy Under Therapeutic Hypothermia
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.
Read the 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.
- Conditions
- Hypoxic-Ischemic Encephalopathy
- Being tested
- Minimal enteral nutrition, Distilled water
- Keywords
- Therapeutic hypothermia, Minimal enteral nutrition, Mesenteric oxygenation, Mesenteric blood flow, Splanchnic oxygenation, Cerebrosplanchnic ratio
- Medical subject headings
- Hypoxia-Ischemia, Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimal enteral nutritionDietary supplement
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.
Distilled waterDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Infants receiving MEN | Active comparator | The babies fed with minimal enteral nutrition during TH constituted the study group Receives: Dietary Supplement: Minimal enteral nutrition |
| Infants receiving placebo | Placebo comparator | The babies who were given distilled water during TH Receives: Dietary Supplement: Distilled water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral and mesenteric blood flow velocities and oxygenation
Cerebral and mesenteric blood flow velocities with Doppler US
Measured: (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
Measured: (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 (3)
Development of NEC
The infants will be monitorized for NEC development
Measured: From admission to NICU till postnatal 15th day or hospital discharge whichever came first,
Feeding intolerance
The infants will be monitorized for feeding intolerance
Measured: 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.
Measured: From admission to NICU till postnatal 15th day or hospital discharge whichever came first,
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start1 Sep 2020
- Primary completion31 Aug 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoxic-Ischemic EncephalopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, DİDEM ARMAN, Istanbul Training and Research Hospital
- Investigators
- DİDEM ARMAN, Principal investigator, Istanbul Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06344286
- Sponsor's protocol ID
- IstanbulTRH-DArman-002
- Status last verified
- Mar 2024
- First submitted
- 12 Mar 2024
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Minimal Enteral Nutrition on Mesenteric Blood Flow and Oxygenation Among Neonates With Hypoxic-ischemic Encephalopathy Under Therapeutic Hypothermia
- ClinicalTrials.gov ID
- NCT06344286
- Acronym / sponsor ID
- IstanbulTRH-DArman-002
- Conditions
- Hypoxic-Ischemic Encephalopathy
- Keywords
- Therapeutic hypothermia, Minimal enteral nutrition, Mesenteric oxygenation, Mesenteric blood flow, Splanchnic oxygenation, Cerebrosplanchnic ratio
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Istanbul Training and Research HospitalOther government
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 3 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Infants receiving MEN | Active comparator | Dietary Supplement: Minimal enteral nutritionThe babies fed with minimal enteral nutrition during TH constituted the study group |
| Infants receiving placebo | Placebo comparator | Dietary Supplement: Distilled waterThe babies who were given distilled water during TH |
Who may qualify
- Ages
- 0 days to 1 day
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minimal enteral nutritionThe 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 supplement | Infants receiving MEN |
| Distilled waterThe 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 supplement | Infants receiving placebo |
Primary outcome
Cerebral and mesenteric blood flow velocities and oxygenation
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 blood flow velocities with Doppler US
Cerebral and mesenteric rSO2 values
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
Cerebral and mesenteric rSO2 values with NIRS
3 secondary outcomes
Development of NEC
Time frame: From admission to NICU till postnatal 15th day or hospital discharge whichever came first,
Feeding intolerance
Time frame: From admission to NICU till postnatal 15th day or hospital discharge whichever came first,
Time to full enteral feeding
Time frame: From admission to NICU till postnatal 15th day or hospital discharge whichever came first,
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
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Hypoxic-Ischemic Encephalopathy
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Levetiracetam as an Adjuvant Therapy to Hypothermia in Neonatal Asphyxia
Hypoxic Ischemic Encephalopathy of Newborn, Neuro-protection
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Minimal Sedation Versus Standard Continuous Sedation After Out-of-Hospital Cardiac Arrest
Out-of-Hospital Cardiac Arrest, Hypoxic-Ischemic Brain Injury
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Neuro-MoD: Neuroplasticity With Motor Development
Perinatal Brain Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
DİDEM ARMAN principal investigator
Istanbul Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimal enteral nutrition and Distilled water in people with Hypoxic-Ischemic Encephalopathy, run by Istanbul Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral and mesenteric blood flow velocities and oxygenation (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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024.