Intrauterine Growth RetardationNCT05513495
The Effect of Neonatal Feeding Modalities on Splanchnic Oxygenation
A study testing The effect of drip versus intermittent feeding on splanchnic oxygenation in people with Intrauterine Growth Retardation and Feeding Patterns, run by Ozge Surmeli Onay at 1 site in Turkey (Türkiye).
Trial summary
OBJECTIVES: The main purpose of this study was to evaluate the impact of drip versus intermittent feeding on splanchnic oxygenation in preterm infants with intrauterine growth restriction (IUGR). Read more about this study
- Who is it for?
- Ages 1 minute to 3 months
- Conditions the study is for
- Intrauterine Growth Retardation, Feeding Patterns, Splanchnic Hypoperfusion
- What is being tested?
- The effect of drip versus intermittent feeding on splanchnic oxygenation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 1 Dec 2021
- 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 1 minute to 3 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Doppler measurements must be performed in fetuses with IUGR
- Preterm infants (GA<37 weeks) with IUGR who were evaluated by Doppler ultrasound were eligible for the study
- These preterm infants must have no enteral nutrition prior to enrolment.
Who cannot join
- Chromosomal or major congenital abnormalities that may influence the ability to monitor the splanchnic bed (congenital heart defects, abdominal wall defects, or congenital diaphragmatic hernia)
- Inherited metabolic diseases
- Hydrops fetalis
- TORCH infection
- Multiorgan failure
- Infants with spontaneous intestinal perforation
- Infants with skin lesions at the site of sensor placement
- Infants who were hospitalized for shorter than 7 days because of discharge or death
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Drip Versus Intermittent Feeding on Splanchnic Oxygenation in Preterm Infants With Intrauterine Growth Retardation: A Prospective Randomized Trial
OBJECTIVES: The main purpose of this study was to evaluate the impact of drip versus intermittent feeding on splanchnic oxygenation in preterm infants with intrauterine growth restriction (IUGR). The second objective was to assess the relationship between fetal splanchnic circulation parameters and splanchnic oxygenation during the first week of life.
METHODS: A single-center, prospective, randomized study with 51 fetuses/infants was conducted. Fetal Doppler measurements including umbilical artery, middle cerebral artery, and superior mesenteric artery (SMA) were recorded in IUGR fetuses. After preterm delivery the infants were randomly assigned to one of two feeding modalities: drip (3-hour continuous) or intermittent (bolus in 10 minutes). Continuous regional splanchnic saturation (rSO2S) monitoring was carried out during first week of life, simultaneously with continuous oxygen arterial saturation (SaO2) monitoring and the infants' fractional oxygen extractions (FOE) were calculated. These parameters were evaluated as means on a daily basis for the first week of life, as well as pre-prandial and post-prandial measurements on the seventh day.
Read more
RESULTS: Fetal Doppler flow velocimetry disturbances were present in 72.5% of the study cohort. The Drip (26 infants) and Intermittent (25 infants) groups were similar in demographic and clinical characteristics, as well as the prevalence of feeding intolerance and necrotizing enterocolitis. During the first week of life, there was no difference in daily mean rSO2S and FOE values between the Drip and Intermittent groups, whereas unfed infants had mostly lower rSO2S values. Pre-prandial and post-prandial rSO2S values remained stable in both groups. Also, no association was detected between fetal splanchnic circulation parameters and neonatal splanchnic oxygenation. RSO2S values were strongly correlated to gestational age and birth weight. During the whole week, except for the first two days, infants with umbilical catheters had significantly lower rSO2S values than infants without.
CONCLUSIONS: Our data suggests that the key factor in splanchnic oxygenation is feeding, not the feeding modality. In addition, the umbilical vein catheter had a negative impact on splanchnic oxygenation.
Read the detailed description
Study design This single-center prospective randomized study was conducted in a university hospital between 1 January 2019-1 October 2021. This work has been supported by Eskisehir Osmangazi University Scientific Research Projects Coordination Unit under grant number 61690618-604.99-E.61140. This study was conducted in conformity with the principles and regulations of the Helsinki Declaration. The Institutional Ethics Committee approved the study (No: 80558721-050.99-E.105607) and informed consent forms were received from all parents/legal guardians of each fetus/infant before inclusion in the study.
Study Cohort The inclusion criteria were that the parents agreed to participate in the study and that Doppler measurements could be performed in fetuses with IUGR and following preterm birth (GA<37 weeks) with no enteral nutrition prior to enrolment. The infants with chromosomal or major congenital abnormalities that may influence the ability to monitor the splanchnic bed (congenital heart defects, abdominal wall defects, or congenital diaphragmatic hernia), inherited metabolic diseases, hydrops fetalis, TORCH infection, multiorgan failure, infants with spontaneous intestinal perforation, infants with skin lesions at the site of sensor placement and infants who were hospitalized shorter than 7 days because of discharge or death were excluded from the study.
- Being tested
- The effect of drip versus intermittent feeding on splanchnic oxygenation
- Keywords
- fetal superior mesenteric artery, Intrauterine Growth Retardation, drip feeding, intermittent feeding, regional splanchnic saturation, umbilical catheter
- Medical subject headings
- Fetal Growth Retardation, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The effect of drip versus intermittent feeding on splanchnic oxygenationOther
After preterm delivery the infants were randomly assigned to one of two feeding modalities: drip (3-hour continuous) or intermittent (bolus in 10 minutes).
| Study group | Role | What they receive |
|---|---|---|
| Drip Group | Active comparator | Each infant received the same amount of feed via continuous administration for 3 hours, and subsequent feeding resumed 1 hour after the end of continuous feeding. All of the infants were fed through an orogastric tube that was attached to a syringe infusion pump for continuous feeding. Once a full enteral feed of 120 mL/kg/day was achieved, the drip feeding was stopped. Receives: Other: The effect of drip versus intermittent feeding on splanchnic oxygenation |
| Intermittent Group | Active comparator | Every 3 hours (×8/day), each infant received a 10-minute gravity bolus of milk/preterm formula via orogastric tube. Receives: Other: The effect of drip versus intermittent feeding on splanchnic oxygenation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fetal SMA Doppler measurements
Antenatal SMA doppler measurements such as pulsatility index
Measured: The last ultrasound study within 48 hours prior delivery was used for analysis.
Daily mean rSO2S&FOE during the first week of life
Splanchnic saturation and fractional tissue oxygen extractions during the first week of life
Measured: Continuous rSO2S monitoring was carried out during first week of life.
Pre-prandial and post-prandial rSO2S&FOE
Splanchnic saturation and fractional tissue oxygen extractions at the 7th day of life related to feeding modalities (drip vs intermittent feeding).
Measured: During seventh day of life, the machine's marking button was pressed when the feeding began (09:00 am and 21:00 pm feeding practices were evaluated for each infant).
The incidence of feeding intolerance, necrotising enterocolitis and time to full enteral feeding
These outcome parameters were evaluated during neonatal intensive care stay
Measured: From admission to discharge
Secondary outcomes (1)
The relationship between fetal splanchnic circulation parameters and neonatal splanchnic oxygenation.
The relation between fetal SMA doppler parameters and regional splanchnic saturation measurements
Measured: Perinatal period (from 48 hours before delivery to first week of life)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2022
- Study start1 Jan 2019
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intrauterine Growth RetardationStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A single-center, prospective, randomized trial
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ozge Surmeli Onay
- Sponsor type
- University, hospital or other
- Collaborators
- Eskisehir Osmangazi University
- Responsible party
- Sponsor-investigator, Ozge Surmeli Onay, Eskisehir Osmangazi University
- Investigators
- Ozge Surmeli Onay, Principal investigator, Eskisehir Osmangazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05513495
- Sponsor's protocol ID
- EskisehirOU-OSOnay-1
- Status last verified
- Aug 2022
- First submitted
- 22 Aug 2022
- Last updated
- 24 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Surmeli Onay O, Velipasaoglu M, Tutal M, Sarilar TD, Cakil Saglik A, Bilgin M, Aydemir O, Barsan Kaya T, Tanir HM, Tekin AN. The effect of drip versus intermittent feeding on splanchnic oxygenation in preterm infants with intrauterine growth restriction: a prospective randomized trial. Eur J Pediatr. 2023 Mar;182(3):1317-1328. doi: 10.1007/s00431-023-04810-x. Epub 2023 Jan 13.
PubMed 36637540
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Drip Versus Intermittent Feeding on Splanchnic Oxygenation in Preterm Infants With Intrauterine Growth Retardation: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT05513495
- Acronym / sponsor ID
- EskisehirOU-OSOnay-1
- Keywords
- fetal superior mesenteric artery, Intrauterine Growth Retardation, drip feeding, intermittent feeding, regional splanchnic saturation, umbilical catheter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Ozge Surmeli OnayUniversity, hospital or other
- Collaborators
- Eskisehir Osmangazi University
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 24 Aug 2022 (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.
OBJECTIVES: The main purpose of this study was to evaluate the impact of drip versus intermittent feeding on splanchnic oxygenation in preterm infants with intrauterine growth restriction (IUGR). The second objective was to assess the relationship between fetal splanchnic circulation parameters and splanchnic oxygenation during the first week of life.
METHODS: A single-center, prospective, randomized study with 51 fetuses/infants was conducted. Fetal Doppler measurements including umbilical artery, middle cerebral artery, and superior mesenteric artery (SMA) were recorded in IUGR fetuses. After preterm delivery the infants were randomly assigned to one of two feeding modalities: drip (3-hour continuous) or intermittent (bolus in 10 minutes). Continuous regional splanchnic saturation (rSO2S) monitoring was carried out during first week of life, simultaneously with continuous oxygen arterial saturation (SaO2) monitoring and the infants' fractional oxygen extractions (FOE) were calculated. These parameters were evaluated as means on a daily basis for the first week of life, as well as pre-prandial and post-prandial measurements on the seventh day.
RESULTS: Fetal Doppler flow velocimetry disturbances were present in 72.5% of the study cohort. The Drip (26 infants) and Intermittent (25 infants) groups were similar in demographic and clinical characteristics, as well as the prevalence of feeding intolerance and necrotizing enterocolitis. During the first week of life, there was no difference in daily mean rSO2S and FOE values between the Drip and Intermittent groups, whereas unfed infants had mostly lower rSO2S values. Pre-prandial and post-prandial rSO2S values remained stable in both groups. Also, no association was detected between fetal splanchnic circulation parameters and neonatal splanchnic oxygenation. RSO2S values were strongly correlated to gestational age and birth weight. During the whole week, except for the first two days, infants with umbilical catheters had significantly lower rSO2S values than infants without.
CONCLUSIONS: Our data suggests that the key factor in splanchnic oxygenation is feeding, not the feeding modality. In addition, the umbilical vein catheter had a negative impact on splanchnic oxygenation.
Detailed description
Study design This single-center prospective randomized study was conducted in a university hospital between 1 January 2019-1 October 2021. This work has been supported by Eskisehir Osmangazi University Scientific Research Projects Coordination Unit under grant number 61690618-604.99-E.61140. This study was conducted in conformity with the principles and regulations of the Helsinki Declaration. The Institutional Ethics Committee approved the study (No: 80558721-050.99-E.105607) and informed consent forms were received from all parents/legal guardians of each fetus/infant before inclusion in the study.
Study Cohort The inclusion criteria were that the parents agreed to participate in the study and that Doppler measurements could be performed in fetuses with IUGR and following preterm birth (GA<37 weeks) with no enteral nutrition prior to enrolment. The infants with chromosomal or major congenital abnormalities that may influence the ability to monitor the splanchnic bed (congenital heart defects, abdominal wall defects, or congenital diaphragmatic hernia), inherited metabolic diseases, hydrops fetalis, TORCH infection, multiorgan failure, infants with spontaneous intestinal perforation, infants with skin lesions at the site of sensor placement and infants who were hospitalized shorter than 7 days because of discharge or death were excluded from the study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A single-center, prospective, randomized trial
| Arm | Type | Receives |
|---|---|---|
| Drip Group | Active comparator | Other: The effect of drip versus intermittent feeding on splanchnic oxygenationEach infant received the same amount of feed via continuous administration for 3 hours, and subsequent feeding resumed 1 hour after the end of continuous feeding. All of the infants were fed through an orogastric tube that was attached to a syringe infusion pump for continuous feeding. Once a full enteral feed of 120 mL/kg/day was achieved, the drip feeding was stopped. |
| Intermittent Group | Active comparator | Other: The effect of drip versus intermittent feeding on splanchnic oxygenationEvery 3 hours (×8/day), each infant received a 10-minute gravity bolus of milk/preterm formula via orogastric tube. |
Who may qualify
- Ages
- 1 minute to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Doppler measurements must be performed in fetuses with IUGR
- Preterm infants (GA<37 weeks) with IUGR who were evaluated by Doppler ultrasound were eligible for the study
- These preterm infants must have no enteral nutrition prior to enrolment.
Key exclusion criteria (8 listed)
- Chromosomal or major congenital abnormalities that may influence the ability to monitor the splanchnic bed (congenital heart defects, abdominal wall defects, or congenital diaphragmatic hernia)
- Inherited metabolic diseases
- Hydrops fetalis
- TORCH infection
- Multiorgan failure
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 |
|---|---|---|
| The effect of drip versus intermittent feeding on splanchnic oxygenationAfter preterm delivery the infants were randomly assigned to one of two feeding modalities: drip (3-hour continuous) or intermittent (bolus in 10 minutes). | Other | Drip Group, Intermittent Group |
Primary outcome
Fetal SMA Doppler measurements
Time frame: The last ultrasound study within 48 hours prior delivery was used for analysis.
Antenatal SMA doppler measurements such as pulsatility index
Daily mean rSO2S&FOE during the first week of life
Time frame: Continuous rSO2S monitoring was carried out during first week of life.
Splanchnic saturation and fractional tissue oxygen extractions during the first week of life
Pre-prandial and post-prandial rSO2S&FOE
Time frame: During seventh day of life, the machine's marking button was pressed when the feeding began (09:00 am and 21:00 pm feeding practices were evaluated for each infant).
Splanchnic saturation and fractional tissue oxygen extractions at the 7th day of life related to feeding modalities (drip vs intermittent feeding).
The incidence of feeding intolerance, necrotising enterocolitis and time to full enteral feeding
Time frame: From admission to discharge
These outcome parameters were evaluated during neonatal intensive care stay
1 secondary outcome
The relationship between fetal splanchnic circulation parameters and neonatal splanchnic oxygenation.
Time frame: Perinatal period (from 48 hours before delivery to first week of life)
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 24 Aug 2022.
- Derived from this study: PubMed 36637540Surmeli Onay O, Velipasaoglu M, Tutal M, Sarilar TD, Cakil Saglik A, Bilgin M, Aydemir O, Barsan Kaya T, Tanir HM, Tekin AN. The effect of drip versus intermittent feeding on splanchnic oxygenation in preterm infants with intrauterine growth restriction: a prospective randomized trial. Eur J Pediatr. 2023 Mar;182(3):1317-1328. doi: 10.1007/s00431-023-04810-x. Epub 2023 Jan 13.
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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.
Ozge Surmeli Onay principal investigator
Eskisehir Osmangazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The effect of drip versus intermittent feeding on splanchnic oxygenation in people with Intrauterine Growth Retardation and Feeding Patterns, run by Ozge Surmeli Onay 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 3 inclusion and 8 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 24 Aug 2022. 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. 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?
Fetal SMA Doppler measurements (time frame: The last ultrasound study within 48 hours prior delivery was used for analysis.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05513495, which also lists 1 linked publication.
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 24 Aug 2022.