Clinical Trial to Evaluate Two Guidelines for the Administration of Ibuprofen in the Treatment of Persistent Ductus Arteriosus Eco-guided: Impact in the Intestinal Prognosis

Persistent Ductus Arteriosus Clinical Trial

— IBU24h-EchoG  

Official title:

Phase III Clinical Trial, Randomized, Multicentre, Double Blind to Evaluate Two Guidelines for the Administration of Ibuprofen in the Treatment of Persistent Ductus Arteriosus Eco-guided: Impact in the Intestinal Prognosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04282941
• Other study ID #: 2016-002974-11
• Status: Recruiting
• Phase: Phase 3
• Start date: February 20, 2017
• Est. completion date: November 30, 2020

Study information

• Verified date: July 2020
• Source: Instituto de Investigación Hospital Universitario La Paz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Persistent ductus arteriosus (DA) is a common entity in the premature newborn and is associated with high morbidity and mortality. There is still controversy about which is the best treatment for its closure. Children with AD who receive pharmacological treatment present more frequently than other premature children, necrotizing enterocolitis or isolated intestinal perforation.

At the present time, the conventional treatment of DA consists in the administration of intravenous ibuprofen, slow bolus in 3 daily doses 10-5-5 mg / kg / day. Recently, it has been observed that treatment with ibuprofen in continuous iv infusion for 3 days seems to be more effective in closing DA than conventional treatment for 3 days with the same dose but in slow iv bolus. This experimental treatment reduced the incidence of associated necrotizing enterocolitis. Our group demonstrated in a previous pilot trial that the guided treatment with echocardiography (EchoG) of DA with ibuprofen compared with conventional treatment, allows to reduce the number of doses to the patient. The EchoG treatment thus presents a potential reduction of side effects associated with medication, this resulted in a tendency to have a lower incidence of necrotising enterocolitis in the experimental group. This multicenter clinical trial aims to test the hypothesis that the combination of 2 experimental treatments, the use of ibuprofen in continuous perfusion and EchoG, reduces the incidence of digestive side effects (necrotising enterocolitis or isolated intestinal perforation) compared to the treatment also guided by echocardiography but slow bolus iv.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: November 30, 2020
• Est. primary completion date: January 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 33 Weeks

Eligibility

Inclusion Criteria:

• Preterm infants with less 33 weeks of gestational age

• DA = 1.5 mm with decision to start pharmacological treatment

• Informed consent signed by the legal representative

Exclusion Criteria:

• Consent denied

• Presence of serious congenital alterations

• Congenital heart disease

• Contraindication for the administration of IB: oligoanuria (diuresis <1cc / kg / h), bleeding severe recent intraventricular (HIV grade III or extensive periventricular hemorrhagic infarction), serum creatinine> 1.5 mg / dl or clinical suspicion of intestinal ischemia.

Related Conditions & MeSH terms

• Ductus Arteriosus, Patent
• Persistent Ductus Arteriosus

Intervention

Drug:
• Ibuprofen in continuous (24 hours) iv infusion and EchoG
The first dose of ibuprofen will be 10 mg / kg to be administered as a continuous infusion for 24 hours. An echocardiogram will be performed before each of the following 2 doses of 5 mg / Kg and will only be administered if it meets echocardiographic criteria that indicate open DA (observation of ductus permeability with color Doppler regardless of its size). Each dose will be administered as a 24-hour continuous infusion.
• IV bolus Ibuprofen slow (15 minutes) and EchoG
The first dose of ibuprofen of 10 mg / Kg to be administered in slow iv bolus (15 minutes). Before each of the following 2 doses of 5 mg / Kg, echocardiography will be performed and will only be administered if it meets the echocardiographic criteria indicated by open DA (observation of ductus permeability in color Doppler regardless of its size). Each dose will be administered in iv boluses in 15 minutes

Locations

Country	Name	City	State
Spain	Hospital 12 de Octubre	Madrid
Spain	Hospital Quirón Salud Madrid	Madrid
Spain	Hospital Universitario La Paz	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Investigación Hospital Universitario La Paz

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To Assess the incidence of neonatal morbidity associated with each of the forms of treatment	Assess the incidence of neonatal morbidity associated with each of the forms of treatment	up to 40 Weeks Postmenstrual age
Other	To Assess the neonatal mortality associated with each of the forms of treatment	Assess the neonatal mortality associated with each of the forms of treatment	up to 40 Weeks Postmenstrual age
Primary	Change the incidence of necrotizing enterocolitis or isolated intestinal perforation in preterm infants receiving treatment for closure of AD with ibuprofen in continuous IV perfusion and EchoG vs iv and EchoG boluses	Change the incidence of necrotizing enterocolitis or isolated intestinal perforation in preterm infants receiving treatment for closure of AD with ibuprofen in continuous IV perfusion and EchoG vs iv and EchoG boluses	40 weeks
Secondary	To Identify genetic polymorphisms asociated to refractory medical treatment of AD and in those most vulnerable to presenting necrotizing enterocolitis or isolated intestinal perforation.	Identify genetic polymorphisms in patients refractory to medical treatment of AD and in those most vulnerable to presenting necrotizing enterocolitis or isolated intestinal perforation.	Day 0(Visit 1)