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Effects of Prostaglandin E1 Treatment on Pyloric Wall in Newborns

NCT04496050 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2020-08-03

No results posted yet for this study

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

Interventions

DRUG

Prostaglandin E1

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

Sponsors & Collaborators

  • Hacettepe University

    lead OTHER

Principal Investigators

  • Hasan T Celik, Ass Prof. · Hacettepe University

Eligibility

Max Age
28 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-06
Primary Completion
2020-11-30
Completion
2020-11-30
FDA Drug
Yes

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04496050 on ClinicalTrials.gov