Patent Ductus Arteriosus and Splanchnic Oxygenation at First Feed

NCT03723889 | Completed

• 1 other identifier: SO-NIRS-PDA
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Patent Ductus Arteriosus

Keywords

Near Infrared Spectroscopy; preterm infants; intestinal complications

Outcome Measures

Primary Outcomes (2)

• 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

  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

  3.5 hours

Study Arms (2)

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.

Eligibility Criteria

• Age: 1 Day - 3 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• \- major congenital malformations, including congenital heart disease

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Related Publications (6)

• 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.

  PMID: 27088709 BACKGROUND

• Freeman-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.

  PMID: 15815707 BACKGROUND

• Havranek 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.

  PMID: 24824108 BACKGROUND

• Petrova 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.

  PMID: 21252960 BACKGROUND

• Martini 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.

  PMID: 29472709 BACKGROUND

• Martini 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.

  PMID: 31211764 DERIVED

MeSH Terms

Conditions

Ductus Arteriosus, Patent

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 26, 2018
• First Posted: October 30, 2018
• Study Start: November 1, 2013
• Primary Completion: October 31, 2016
• Study Completion: October 31, 2016
• Last Updated: December 26, 2018

Record last verified: 2018-12