Effects of Prostaglandin E1 Treatment on Pyloric Wall in Newborns

NCT04496050 | Unknown FDA Drug

• 1 other identifier: KA-19044
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Prostaglandin E1 (PGE1) has been used in the medical treatment of ductal dependent critical congenital heart disease in neonates. Apnea/ bradycardia, hypotension, hypokalemia, feeding difficulties, fever, jitteriness are the most important side effects of PGE1. Also gastric outlet has been reported. We aimed to determine effect of PGE1 treatment on pyloric wall thickness in newborn period. In this study, the side effect of increase of pylorus muscle wall thickness will be monitored with weekly ultrasonography. No intervention in the treatment, medical decisions and follow-up of these patients will be made. After reaching the sufficient number of cases (20 cases), increases in the pyloric wall thickness dimensions will be compared with statistical analysis. The number of cases was determined in accordance with the rate of hospitalization in our unit during the determined period (18 months).

Conditions

Pyloric Stenosis;Acquired; Congenital Heart Disease

Keywords

Congenital Heart Disease; Prostaglandine E1 treatment; Prostaglandine E1 Side Effects; pyloric wall thickness

Outcome Measures

Primary Outcomes (1)

• Effect of prostaglandin E1 treatment on pyloric wall thickness in newborn period

  It is aimed to evaluate whether there is a possible increase in pyloric wall thickness in newborn babies given Prostaglandin E1 due to any congenital heart disease.

  18 months

Secondary Outcomes (1)

• Measurement of pyloric wall thickness after discontinuation of prostaglandin E1 infusion

  18 months

Study Arms (1)

one

there is only one patient group. This group of patients, given the same dose and at the same time, is examined by ultrasonography to determine the thickness of the pyloric muscle.

Drug: Prostaglandin E1

Interventions

Prostaglandin E1 DRUG

The same drug will be used. In this study the same patients will be evaluated after the same dose of medication.

one

Eligibility Criteria

• Age: Up to 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Newborn babies between 0- 28 days.

You may qualify if:

• Newborn babies who are hospitalized in Hacettepe University Faculty of Medicine İhsan Doğramacı Children's Hospital Neonatal Intensive Care Unit and who are receiving prostaglandin E1 infusion due to PDA-dependent congenital heart disease.
• Newborns who have the above criteria and whose consent form has been enlightened by their parents has been read and accepted to participate in the study.

You may not qualify if:

• Babies whose consent to participate in the study cannot be obtained.
• Babies with chromosomal disease or hereditary metabolic disease
• Babies who died during the first week of life and whose ultrasonography measurements could not be obtained.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

Location

Related Publications (1)

• Tandircioglu UA, Turer OB, Soyer T, Ayaz E, Ozcan HN, Yigit S, Celik HT. Effect of prostaglandin-E1 treatment on pyloric wall thickness in newborns with ductal-dependent critical congenital heart diseases. Pediatr Surg Int. 2023 Mar 1;39(1):144. doi: 10.1007/s00383-023-05428-8.

  PMID: 36856877 DERIVED

Related Links

• Case report
• Complications of Long-Term Prostaglandin E1 Use in Newborns With Ductal-Dependent Critical Congenital Heart Disease

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Alprostadil

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Prostaglandins E; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Fatty Acids, Monounsaturated; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Hasan T Celik, Ass Prof.

  Hacettepe University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: July 28, 2020
• First Posted: August 3, 2020
• Study Start: May 6, 2019
• Primary Completion: November 30, 2020
• Study Completion: November 30, 2020
• Last Updated: August 3, 2020

Record last verified: 2020-07

Locations

TU (1)