Effects of Prostaglandin E1 Treatment on Pyloric Wall in Newborns (EOPTOPWT)

Effect Of Prostaglandin E1 Treatment On Pyloric Wall Thickness in Newborns With Ductal Dependent Critical Congenital Heart Diseases

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).

Study Overview

• Status: Unknown
• Conditions: Congenital Heart Disease; Pyloric Stenosis;Acquired
• Intervention / Treatment: Drug: Prostaglandin E1

Detailed Description

Intravenous prostaglandin E1 infusion is referred to as ductus dependent diseases, in systemic (aortic blood flow) circulation (eg critical aortic coarctation, intermittent arcus aorta, hypoplastic left heart, transposition of great artery), or lung blood flow through patent ductus arteriosus ( For example, pulmonary valve atresia, tricuspid valve atresia, hypoplastic right heart) is a life-saving drug used to ensure that the duct remains open until a full, partial or temporary surgical correction or intervention is made. In the antenatal period, the placenta is a good source of prostaglandins. However, with the disappearance of the placental circulation after birth, many mechanisms ensure that the patent ductus arteriosus closes first functional and then anatomically. Due to these mechanisms occurring in the early days of life, babies who have ductus-dependent congenital heart diseases show themselves with severe clinical signs and symptoms such as cyanosis and circulatory disorders in this early neonatal period, when ductus begins to close when diagnosis and treatment are not performed. Echocardiography should be performed by the pediatric cardiology specialist as soon as possible after delivery to babies diagnosed in the antenatal period, and if a ductus-dependent congenital heart disease diagnosis is confirmed, PGE1 infusion should be started immediately, and the patient should be consulted with a pediatric cardiovascular surgery specialist and a surgical intervention plan should be provided as soon as possible.Due to these mechanisms occurring in the early days of life, babies who have ductus-dependent congenital heart diseases show themselves with severe clinical signs and symptoms such as cyanosis and circulatory disorders in this early neonatal period, when ductus begins to close when diagnosis and treatment are not performed. Echocardiography should be performed by the pediatric cardiology specialist as soon as possible after delivery to babies diagnosed in the antenatal period, and if a ductus-dependent congenital heart disease diagnosis is confirmed, PGE1 infusion should be started immediately, and the patient should be consulted with a pediatric cardiovascular surgery specialist and a surgical intervention plan should be provided as soon as possible. Prostaglandin E1 infusion is given as a continuous intravenous infusion. PGE1 has some side effects. The most common side effects are apnea, hyperthermia, and vasodilatation on the skin, they occur around 10-14% and are usually dose-related side effects. In addition, bradycardia, hypotension, convulsion, tachycardia, diarrhea, sepsis, necrotizing enterocolitis, hypernatremia, hyponatremia, hypokalemia, respiratory depression, arrhythmia, congestive heart failure, gastric regurgitation, bleeding, anuria, hematuria and hypoglycaemia are more rare effects. The frequency and severity of these side effects usually depend on the dose of the drug and the time used. Many of these side effects disappear or decrease significantly when the medication is stopped or the dose is reduced. An important complication that can be seen with long-term use is cortical hyperostosis in long bones. Among the very rare side effects of the drug Prostaglandin E1 are hyperplasia of the gastric mucosa and the development of pyloric stenosis.Hypertrophic pyloric stenosis develops as a result of hypertrophy of circular pyloric muscles in the newborn period. Ultrasonography (USG) is the primary diagnosis and imaging method, because it does not contain radiation, it has replaced contrast studies. In ultrasonography, the thickness of the pyloric muscle from the mucosa to the serosa is more than 2-3 mm and the length of the pyloric canal is over 16 mm. In the literature, there is no study on the effect of PGE1 increasing the pyloric wall thickness in newborns, there is a case report from our hospital in this regard. In this study, we aimed to evaluate the effects of the drug on pyloric wall thickness prospectively with weekly ultrasonography measurements in infants given PGE1 infusion due to congenital heart disease. Ultrasonography measurements will be made at the bedside (with the ultrasonography device of our unit) by an experienced pediatric radiologist in pediatric cases. No intervention in the treatment, medical decisions and follow-up of patients will be made. Neonatal babies who were born in Hacettepe University Faculty of Medicine Ihsan Dogramaci Children's Hospital Neonatal Intensive Care Unit and who were receiving prostaglandin E1 infusion due to PDA-dependent congenital heart disease will be included in the study. Infants who do not have consent to participate, babies with chromosomal disease and hereditary metabolic disease will not be included in the study. In addition, babies who have an exitus in the first week of life and whose ultrasonography measurements cannot be obtained, and babies whose prostaglandin E1 infusion is discontinued by taking the second ultrasonographic measurement in the first week of life will be excluded from the study.

Study Design:

• Patients who have to receive Prostaglandin E1 treatment due to congenital heart disease followed in the neonatal department of our hospital will be included in the study after their consent and approval with their families without recording their identity information.
• Pyloric thicknesses will be measured by a pediatric radiologist once a week (at least twice) during the period when patients use PGE1.
• 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). In this way, since the studies are in the form of a case report and the original article cannot be found in the literature, the observed power of the study will be calculated after the study is completed.

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • Hacettepe University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Newborn babies between 0- 28 days.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; The same drug will be used. In this study the same patients will be evaluated after the same dose of medication.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of pyloric wall thickness after discontinuation of prostaglandin E1 infusion	The side effect of PGE1, which is increased pyloric wall thickness, is temporary. We aimed that after discontinuation of the drug, babies pyloric wall thickness will normal.	18 months

Collaborators and Investigators

• Sponsor: Hacettepe University
• Investigators: Study Chair: Hasan T Celik, Ass Prof., Hacettepe University

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2019
• Primary Completion (Anticipated): November 30, 2020
• Study Completion (Anticipated): November 30, 2020

Study Registration Dates

• First Submitted: July 28, 2020
• First Submitted That Met QC Criteria: July 30, 2020
• First Posted (Actual): August 3, 2020

Study Record Updates

• Last Update Posted (Actual): August 3, 2020
• Last Update Submitted That Met QC Criteria: July 30, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Congenital Heart Disease; Prostaglandine E1 treatment; Prostaglandine E1 Side Effects; pyloric wall thickness
• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Congenital Abnormalities; Gastrointestinal Diseases; Stomach Diseases; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital; Pyloric Stenosis; Gastric Outlet Obstruction; Vasodilator Agents; Urological Agents; Platelet Aggregation Inhibitors; Alprostadil
• Other Study ID Numbers: KA-19044

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: At the end of the study, the results of the study will be written as an article and shared with the researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No