Effect Of Prostaglandin E1 Treatment On Pyloric Wall Thickness in Newborns With Ductal Dependent Critical Congenital Heart Diseases
Conditions: Pyloric Stenosis;Acquired, Congenital Heart Disease
Sponsor: Hacettepe University

 
EFFECT OF PROSTAGLANDİN 
E1 TREATMENT ON PYLORİC 
WALL 
THİCKNESS 
İN 
NEWBORN PERİOD 
DOCUMENT DATE: MAY 6, 2019 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
Study Protocol: 
Effect of prostaglandin E1 treatment on pyloric wall thickness in newborn period 
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.