Patent Ductus ArteriosusNCT03723889
Patent Ductus Arteriosus and Splanchnic Oxygenation at First Feed
An observational study of Patent Ductus Arteriosus, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna.
Trial summary
Patent ductus arteriosus (PDA) is common in preterm infants. In the presence of a large PDA, significant systemic to pulmonary shunting occurs, which may results in pulmonary hyperperfusion and systemic hypoperfusion. Read more about this study
- Who is it for?
- Ages 1 day to 3 days
- Conditions the study is for
- Patent Ductus Arteriosus
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2013to 31 Oct 2016
- Phase
- Observational
- 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 day to 3 days
- All sexes
- No healthy volunteers
- Child
Study population: Preterm infants admitted to the Neonatal Intensive Care Unit of St. Orsola-Malpighi Hospital
Who may be able to join
- gestational age <32 weeks
- no enteral feeding prior to the enrollment
Who cannot join
- major congenital malformations, including congenital heart disease
About this study
Official title: Effect of Patent Ductus Arteriosus on Splanchnic Oxygenation at Enteral Feeding Introduction in Preterm Infants
Patent ductus arteriosus (PDA) is common in preterm infants. In the presence of a large PDA, significant systemic to pulmonary shunting occurs, which may results in pulmonary hyperperfusion and systemic hypoperfusion. As consequence of splanchnic hypoperfusion ensuing from left-to-right PDA shunting, a possible association between hemodynamically significant PDA and adverse gastrointestinal outcomes has been reported.
An impaired blood flow velocity in superior mesenteric artery, evaluated by Doppler ultrasound, has been previously reported before and after feeds in infants with large PDA, whereas evidence on PDA effect on splanchnic tissue oxygenation, measured by Near Infrared Spectroscopy, is scarce and controversial.
This study aims to evaluate whether splanchnic oxygenation patterns in response to enteral feeding introduction in preterm infants may be affected by PDA status.
Read the detailed description
Patent ductus arteriosus (PDA) is a common condition among preterm infants. In the presence of a large PDA, significant systemic to pulmonary shunting occurs, possibly resulting in pulmonary blood flow overload and systemic hypoperfusion. A possible association with hemodynamically significant PDA and the occurrence of adverse gastrointestinal outcomes has been reported as a possible consequence of mesenteric hypoperfusion ensuing from left-to-right shunt through the PDA.
Previous attempts to assess by Doppler ultrasound the effect of PDA on blood flow velocity in superior mesenteric artery (SMA BFV) showed a decreased SMA BFV before and after feedings and attenuated postprandial increases in infants with large PDA. Near-infrared spectroscopy (NIRS) provides a non-invasive measurement of regional tissue oxygen saturation and has been previously applied in neonatal settings for the monitoring of cerebral (CrSO2) or splanchnic (SrSO2) oxygen saturation. Current evidence on the effect of PDA on SrSO2 is scarce and controversial; moreover, a possible effect of PDA on SrSO2 patterns in response to enteral feeding introduction has not been evaluated yet.
This study aims to evaluate whether SrSO2 patterns in response to enteral feeding introduction in preterm infants may be affected by the ductal status. The development of intestinal complications in relation to PDA are also evaluated.
Preterm infants <32 weeks admitted to the Neonatal Intensive Care Unit (NICU) are consecutively enrolled in the study if younger than 3 days and if no enteral feeding has been administered prior to the enrollment.
Written, informed consent to participate in the study is obtained from the parents/legal guardians of each infant before introducing enteral feeding.
At the time of enteral feeding introduction, the enrolled infants undergo a continuous monitoring of CrSO2 and SrSO2 by means of INVOS 5100 oximeter. NIRS recording is performed from 30 minutes before to 3 hours after feeding administration. CrSO2 and SrSO2 are recorded every 5 seconds. Values recorded before, during and after feeding administration are clustered into 5-minute intervals and considered for statistical analysis. Splanchnic-cerebral oxygen ratio (SCOR), which derives by the ratio between SrSO2 and CrSO2 and has been previously proposed as a valid marker for gut hypoxia-ischemia, is also calculated.
As per normal routine, an echocardiographic evaluation is performed before enteral feeding introduction, in order to evaluate hemodynamics and PDA status of the infant. In relation to the PDA status, enrolled infants are divided into the following groups: PDA (echocardiographic evidence of patent ductus arteriosus at the time of first feed) and noPDA (echocardiographic evidence of closed ductus arterious at the time of first feed).
Neonatal characteristics, including gestational age, birth weight, antenatal Doppler status, and echocardiographic PDA characteristics at the introduction of enteral feeding and the occurrence of intestinal complications during hospital stay, defined as the development of feeding intolerance (enteral feeding withholding for at least 24 hours because of gastrointestinal symptoms), necrotizing enterocolitis and spontaneous intestinal perforation, are recorded in a specific case report form.
SrSO2, CrSO2 and SCOR patterns in response to first feed are evaluated and compared between PDA and noPDA infants and adjusted for possible influencing clinical variables using a multivariate model. Moreover, the rate of intestinal complications is compared between the two study groups by chi-square test. Data are analyzed using IBM SPSS Statistic version 25 (IBM Corporation, IBM Corporation Armonk, New York, United States).
- Conditions
- Patent Ductus Arteriosus
- Keywords
- Near Infrared Spectroscopy, preterm infants, intestinal complications
- Medical subject headings
- Ductus Arteriosus, Patent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PDA | Evidence of patent ductus arteriosus at echocardiography evaluation before enteral feeding introduction. | |
| noPDA | No evidence of patent ductus arteriosus at echocardiography evaluation before enteral feeding introduction. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Between-group SrSO2 difference after enteral feeding introduction
Comparison of SrSO2 values in response to the first enteral feed in infants with evidence of PDA and infants with no evidence of PDA
Measured: 3.5 hours
Between-group SCOR difference after enteral feeding introduction
Comparison of SCOR values in response to the first enteral feed in infants with evidence of PDA and infants with no evidence of PDA
Measured: 3.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2018
- Study start1 Nov 2013
- Primary completion31 Oct 2016
- Study completion31 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Patent Ductus ArteriosusStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luigi Corvaglia, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03723889
- Sponsor's protocol ID
- SO-NIRS-PDA
- Status last verified
- Dec 2018
- First submitted
- 26 Oct 2018
- Last updated
- 26 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
van der Laan ME, Roofthooft MT, Fries MW, Berger RM, Schat TE, van Zoonen AG, Tanis JC, Bos AF, Kooi EM. A Hemodynamically Significant Patent Ductus Arteriosus Does Not Affect Cerebral or Renal Tissue Oxygenation in Preterm Infants. Neonatology. 2016;110(2):141-7. doi: 10.1159/000445101. Epub 2016 Apr 19.
PubMed 27088709Freeman-Ladd M, Cohen JB, Carver JD, Huhta JC. The hemodynamic effects of neonatal patent ductus arteriosus shunting on superior mesenteric artery blood flow. J Perinatol. 2005 Jul;25(7):459-62. doi: 10.1038/sj.jp.7211294.
PubMed 15815707Havranek T, Rahimi M, Hall H, Armbrecht E. Feeding preterm neonates with patent ductus arteriosus (PDA): intestinal blood flow characteristics and clinical outcomes. J Matern Fetal Neonatal Med. 2015 Mar;28(5):526-30. doi: 10.3109/14767058.2014.923395. Epub 2014 May 29.
PubMed 24824108Petrova A, Bhatt M, Mehta R. Regional tissue oxygenation in preterm born infants in association with echocardiographically significant patent ductus arteriosus. J Perinatol. 2011 Jul;31(7):460-4. doi: 10.1038/jp.2010.200. Epub 2011 Jan 20.
PubMed 21252960Martini S, Corvaglia L. Splanchnic NIRS monitoring in neonatal care: rationale, current applications and future perspectives. J Perinatol. 2018 May;38(5):431-443. doi: 10.1038/s41372-018-0075-1. Epub 2018 Feb 22.
PubMed 29472709Martini S, Corvaglia L, Aceti A, Vitali F, Faldella G, Galletti S. Effect of Patent Ductus Arteriosus on Splanchnic Oxygenation at Enteral Feeding Introduction in Very Preterm Infants. J Pediatr Gastroenterol Nutr. 2019 Oct;69(4):493-497. doi: 10.1097/MPG.0000000000002420.
PubMed 31211764
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Patent Ductus Arteriosus on Splanchnic Oxygenation at Enteral Feeding Introduction in Preterm Infants
- ClinicalTrials.gov ID
- NCT03723889
- Acronym / sponsor ID
- SO-NIRS-PDA
- Conditions
- Patent Ductus Arteriosus
- Keywords
- Near Infrared Spectroscopy, preterm infants, intestinal complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 1 Nov 2013 (actual)
- Primary completion
- 31 Oct 2016 (actual)
- Study completion
- 31 Oct 2016 (actual)
- First posted
- 30 Oct 2018 (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.
Patent ductus arteriosus (PDA) is common in preterm infants. In the presence of a large PDA, significant systemic to pulmonary shunting occurs, which may results in pulmonary hyperperfusion and systemic hypoperfusion. As consequence of splanchnic hypoperfusion ensuing from left-to-right PDA shunting, a possible association between hemodynamically significant PDA and adverse gastrointestinal outcomes has been reported.
An impaired blood flow velocity in superior mesenteric artery, evaluated by Doppler ultrasound, has been previously reported before and after feeds in infants with large PDA, whereas evidence on PDA effect on splanchnic tissue oxygenation, measured by Near Infrared Spectroscopy, is scarce and controversial.
This study aims to evaluate whether splanchnic oxygenation patterns in response to enteral feeding introduction in preterm infants may be affected by PDA status.
Detailed description
Patent ductus arteriosus (PDA) is a common condition among preterm infants. In the presence of a large PDA, significant systemic to pulmonary shunting occurs, possibly resulting in pulmonary blood flow overload and systemic hypoperfusion. A possible association with hemodynamically significant PDA and the occurrence of adverse gastrointestinal outcomes has been reported as a possible consequence of mesenteric hypoperfusion ensuing from left-to-right shunt through the PDA.
Previous attempts to assess by Doppler ultrasound the effect of PDA on blood flow velocity in superior mesenteric artery (SMA BFV) showed a decreased SMA BFV before and after feedings and attenuated postprandial increases in infants with large PDA. Near-infrared spectroscopy (NIRS) provides a non-invasive measurement of regional tissue oxygen saturation and has been previously applied in neonatal settings for the monitoring of cerebral (CrSO2) or splanchnic (SrSO2) oxygen saturation. Current evidence on the effect of PDA on SrSO2 is scarce and controversial; moreover, a possible effect of PDA on SrSO2 patterns in response to enteral feeding introduction has not been evaluated yet.
This study aims to evaluate whether SrSO2 patterns in response to enteral feeding introduction in preterm infants may be affected by the ductal status. The development of intestinal complications in relation to PDA are also evaluated.
Preterm infants <32 weeks admitted to the Neonatal Intensive Care Unit (NICU) are consecutively enrolled in the study if younger than 3 days and if no enteral feeding has been administered prior to the enrollment.
Written, informed consent to participate in the study is obtained from the parents/legal guardians of each infant before introducing enteral feeding.
At the time of enteral feeding introduction, the enrolled infants undergo a continuous monitoring of CrSO2 and SrSO2 by means of INVOS 5100 oximeter. NIRS recording is performed from 30 minutes before to 3 hours after feeding administration. CrSO2 and SrSO2 are recorded every 5 seconds. Values recorded before, during and after feeding administration are clustered into 5-minute intervals and considered for statistical analysis. Splanchnic-cerebral oxygen ratio (SCOR), which derives by the ratio between SrSO2 and CrSO2 and has been previously proposed as a valid marker for gut hypoxia-ischemia, is also calculated.
As per normal routine, an echocardiographic evaluation is performed before enteral feeding introduction, in order to evaluate hemodynamics and PDA status of the infant. In relation to the PDA status, enrolled infants are divided into the following groups: PDA (echocardiographic evidence of patent ductus arteriosus at the time of first feed) and noPDA (echocardiographic evidence of closed ductus arterious at the time of first feed).
Neonatal characteristics, including gestational age, birth weight, antenatal Doppler status, and echocardiographic PDA characteristics at the introduction of enteral feeding and the occurrence of intestinal complications during hospital stay, defined as the development of feeding intolerance (enteral feeding withholding for at least 24 hours because of gastrointestinal symptoms), necrotizing enterocolitis and spontaneous intestinal perforation, are recorded in a specific case report form.
SrSO2, CrSO2 and SCOR patterns in response to first feed are evaluated and compared between PDA and noPDA infants and adjusted for possible influencing clinical variables using a multivariate model. Moreover, the rate of intestinal complications is compared between the two study groups by chi-square test. Data are analyzed using IBM SPSS Statistic version 25 (IBM Corporation, IBM Corporation Armonk, New York, United States).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PDA | – | –Evidence of patent ductus arteriosus at echocardiography evaluation before enteral feeding introduction. |
| noPDA | – | –No evidence of patent ductus arteriosus at echocardiography evaluation before enteral feeding introduction. |
Who may qualify
- Ages
- 1 day to 3 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Preterm infants admitted to the Neonatal Intensive Care Unit of St. Orsola-Malpighi Hospital
Key inclusion criteria (2 listed)
- gestational age <32 weeks
- no enteral feeding prior to the enrollment
Key exclusion criteria (1 listed)
- major congenital malformations, including congenital heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Between-group SrSO2 difference after enteral feeding introduction
Time frame: 3.5 hours
Comparison of SrSO2 values in response to the first enteral feed in infants with evidence of PDA and infants with no evidence of PDA
Between-group SCOR difference after enteral feeding introduction
Time frame: 3.5 hours
Comparison of SCOR values in response to the first enteral feed in infants with evidence of PDA and infants with no evidence of PDA
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 26 Dec 2018.
- Background: PubMed 27088709van der Laan ME, Roofthooft MT, Fries MW, Berger RM, Schat TE, van Zoonen AG, Tanis JC, Bos AF, Kooi EM. A Hemodynamically Significant Patent Ductus Arteriosus Does Not Affect Cerebral or Renal Tissue Oxygenation in Preterm Infants. Neonatology. 2016;110(2):141-7. doi: 10.1159/000445101. Epub 2016 Apr 19.
- Background: PubMed 15815707Freeman-Ladd M, Cohen JB, Carver JD, Huhta JC. The hemodynamic effects of neonatal patent ductus arteriosus shunting on superior mesenteric artery blood flow. J Perinatol. 2005 Jul;25(7):459-62. doi: 10.1038/sj.jp.7211294.
- Background: PubMed 24824108Havranek T, Rahimi M, Hall H, Armbrecht E. Feeding preterm neonates with patent ductus arteriosus (PDA): intestinal blood flow characteristics and clinical outcomes. J Matern Fetal Neonatal Med. 2015 Mar;28(5):526-30. doi: 10.3109/14767058.2014.923395. Epub 2014 May 29.
- Background: PubMed 21252960Petrova A, Bhatt M, Mehta R. Regional tissue oxygenation in preterm born infants in association with echocardiographically significant patent ductus arteriosus. J Perinatol. 2011 Jul;31(7):460-4. doi: 10.1038/jp.2010.200. Epub 2011 Jan 20.
- Background: PubMed 29472709Martini S, Corvaglia L. Splanchnic NIRS monitoring in neonatal care: rationale, current applications and future perspectives. J Perinatol. 2018 May;38(5):431-443. doi: 10.1038/s41372-018-0075-1. Epub 2018 Feb 22.
- Derived from this study: PubMed 31211764Martini S, Corvaglia L, Aceti A, Vitali F, Faldella G, Galletti S. Effect of Patent Ductus Arteriosus on Splanchnic Oxygenation at Enteral Feeding Introduction in Very Preterm Infants. J Pediatr Gastroenterol Nutr. 2019 Oct;69(4):493-497. doi: 10.1097/MPG.0000000000002420.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Patent Ductus Arteriosus, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna.
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 2 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 26 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Between-group SrSO2 difference after enteral feeding introduction (time frame: 3.5 hours). 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?
On the ClinicalTrials.gov record for NCT03723889, which also lists 6 linked publications.
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 26 Dec 2018.