Patent Ductus Arteriosus and Splanchnic Oxygenation at First Feed

December 22, 2018 updated by: Luigi Corvaglia, IRCCS Azienda Ospedaliero-Universitaria di Bologna

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

50

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 3 days (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Preterm infants admitted to the Neonatal Intensive Care Unit of St. Orsola-Malpighi Hospital

Description

Inclusion Criteria:

  • gestational age <32 weeks
  • no enteral feeding prior to the enrollment

Exclusion Criteria:

- major congenital malformations, including congenital heart disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3.5 hours
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
3.5 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2013

Primary Completion (Actual)

October 31, 2016

Study Completion (Actual)

October 31, 2016

Study Registration Dates

First Submitted

October 26, 2018

First Submitted That Met QC Criteria

October 26, 2018

First Posted (Actual)

October 30, 2018

Study Record Updates

Last Update Posted (Actual)

December 26, 2018

Last Update Submitted That Met QC Criteria

December 22, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SO-NIRS-PDA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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