Echocardiographically Guided Versus Standard Ibuprofen Treatment for Patent Ductus Arteriosus

NCT01593163 | Completed Phase 3 DMC

• 1 other identifier: IbuEchoG
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

Patent ductus arteriosus (PDA) is a very common condition in immature newborn babies and it has been associated to morbidity and mortality. Ibuprofen is the drug of choice for PDA treatment according to the last version of the Cochrane review. Nowadays the best dose regimen for ibuprofen remains uncertain. The investigators aim to perform a randomized controlled clinical trial to assess whether echocardiographically guided PDA ibuprofen treatment versus standard treatment could reduce the number of doses of ibuprofen without increasing the reopening rate and reducing the side effects associated to this medication.

Conditions

Patent Ductus Arteriosus

Keywords

Functional echocardiography; power Doppler cranial ultrasonography; N-terminal probrain natriuretic peptide; Patent ductus arteriosus

Outcome Measures

Primary Outcomes (1)

• PDA re-opening rate

  PDA re-opening after echocardiographically documented closure, which the attending physician deemed amenable to additional treatment. Infants with ventilator weaning difficulty, protracted metabolic acidosis or persistent hemodynamic instability were included in this category.

  Infants will be followed for the duration of hospital stay in the Newborn Unit, an expected average of 4-8 weeks

Secondary Outcomes (15)

• treatment failure

  Infants will be followed for the duration of hospital stay in the Newborn Unit, an expected average of 4-8 weeks

• need for surgical ligation

  Infants will be followed for the duration of hospital stay in the Newborn Unit, an expected average of 4-8 weeks

• need for additional ibuprofen doses

  Infants will be followed for the duration of hospital stay in the Newborn Unit, an expected average of 4-8 weeks

• urine output

  before the first ibuprofen dose was administered (between 12-72 hours of life) until 24 hours after the last dose of ibuprofen was administered (between 36-168 h of life)

• serum creatinine

  before the first ibuprofen dose was administered (between 12-72 hours of life) until 24 hours after the last dose of ibuprofen was administered (between 36-168 h of life)

Study Arms (2)

EchoG

EXPERIMENTAL

Infants in the experimental group (echoG treatment) received additional doses of ibuprofen only if PDA was still ≥ 1.5 mm at the time of the corresponding ibuprofen dose.

Drug: Ibuprofen EchoG

ST (standard treatment)

OTHER

Infants received 3 doses of ibuprofen at 24-hour intervals, independently of ductal size, as long as additional doses were not contraindicated.

Drug: Standard ibuprofen treatment

Interventions

Ibuprofen EchoG DRUG

Infants in the experimental group (echoG treatment) received additional doses of ibuprofen only if PDA was still ≥ 1.5 mm at the time of the corresponding ibuprofen dose.

Also known as: Echocardiographically guided ibuprofen treatment

EchoG

Standard ibuprofen treatment DRUG

Infants received 3 doses of ibuprofen at 24-hour intervals, independently of ductal size, as long as additional doses were not contraindicated.

ST (standard treatment)

Eligibility Criteria

• Age: Up to 1 Month
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Preterm infants with a gestational age lower than 37 weeks of gestational age
• PDA ≥ 1.5 mm
• No contraindication to receive ibuprofen
• Informed consent signed.

You may not qualify if:

• Life-threatening congenital defects
• Congenital heart disease
• Contraindication for ibuprofen administration such as oligoanuria \< 1cc/kg/h or recent severe intraventricular bleeding (IVH grade III) or creatinine serum level \> 1.5 mg/dl or potential intestinal ischemia.
• Informed consent refused

Sponsors & Collaborators

• Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz: lead

Study Sites (1)

Department of Neonatology, La Paz University Hospital

Madrid, Madrid, 28046, Spain

Location

Related Publications (1)

• Carmo KB, Evans N, Paradisis M. Duration of indomethacin treatment of the preterm patent ductus arteriosus as directed by echocardiography. J Pediatr. 2009 Dec;155(6):819-822.e1. doi: 10.1016/j.jpeds.2009.06.013. Epub 2009 Jul 29.

  PMID: 19643435 BACKGROUND

MeSH Terms

Conditions

Ductus Arteriosus, Patent

Condition Hierarchy (Ancestors)

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

Study Officials

• María Carmen Bravo, PhD MD

  Department of Neonatology, La Paz University Hospital

  PRINCIPAL INVESTIGATOR

• Fernando Cabañas, PhDMD

  Department of Neonatology, La Paz University Hospital

  STUDY CHAIR

• Joan Riera, Bio-Engineer

  Department of Neonatology, La Paz University Hospital

  STUDY CHAIR

• Elia Pérez-Fernández

  Division of Statistics, La Paz University Hospital. Madrid, Spain.

  STUDY CHAIR

• José Quero, PhDMD

  Department of Neonatology, La Paz University Hospital. Madrid, Spain.

  STUDY CHAIR

• Jesús Pérez-Rodríguez, PhDMD

  Department of Neonatology, La Paz University Hospital. Madrid, Spain.

  STUDY CHAIR

• Adelina Pellicer, PhDMD

  Department of Neonatology, La Paz University Hospital. Madrid, Spain.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 3, 2012
• First Posted: May 8, 2012
• Study Start: May 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: May 8, 2012

Record last verified: 2012-05

Locations

ES (1)