Comparing Ibuprofen And Indomethacin For The Treatment Of The Patent Ductus Arteriosus in Very Premature Babies

This study has been withdrawn prior to enrollment.
(Funding withdrawn)
Sponsor:
Collaborators:
National University Hospital, Singapore
Cumberland Pharmaceuticals
Information provided by (Responsible Party):
Quek Bin Huey, KK Women's and Children's Hospital
ClinicalTrials.gov Identifier:
NCT00470743
First received: May 7, 2007
Last updated: September 1, 2015
Last verified: June 2009
  Purpose

The purpose of the study is to determine the safety and efficacy of ibuprofen, compared with indomethacin, in the treatment for the closure of the patent ductus arteriosus in premature babies born under 29 weeks gestation


Condition Intervention Phase
Ductus Arteriosus, Patent
Very Low Birth Weight Infants
Drug: Ibuprofen
Drug: Indomethacin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomised Controlled Trial Comparing Ibuprofen And Indomethacin For The Treatment Of The Patent Ductus Arteriosus In Very Premature Infants

Resource links provided by NLM:


Further study details as provided by KK Women's and Children's Hospital:

Primary Outcome Measures:
  • Incidence of oliguria and gastric bleeding [ Time Frame: within one week of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • PDA closure rates after medical treatment at time of discharge from hospital [ Time Frame: after 1 to 2 courses of treatment ] [ Designated as safety issue: No ]
  • Need for repeat of the second course of medication [ Time Frame: 48 hrs after 3rd dose of treatment ] [ Designated as safety issue: No ]
  • Need for surgical closure [ Time Frame: after 1 to 2 courses of treatment ] [ Designated as safety issue: No ]
  • In-hospital mortality [ Time Frame: while in-hospital ] [ Designated as safety issue: Yes ]
  • Creatinine >140umol/L within one week after the 1st dose of treatment [ Time Frame: one week after 1st dose of treatment ] [ Designated as safety issue: Yes ]
  • Hyponatremia within one week after the 1st dose of treatment [ Time Frame: one week after 1st dose of treatment ] [ Designated as safety issue: Yes ]
  • Gastrointestinal perforation within one week after the 1st dose of treatment [ Time Frame: within one week after the 1st dose of treatment ] [ Designated as safety issue: Yes ]
  • Necrotising enterocolitis within one week after the 1st dose of treatment [ Time Frame: within one week after the 1st dose of treatment ] [ Designated as safety issue: Yes ]
  • Worst grade of IVH by Day 28 of life [ Time Frame: Day 28 of life ] [ Designated as safety issue: Yes ]
  • Pulmonary hypertension within 48hrs after 1st dose of treatment [ Time Frame: within 48hrs after 1st dose of treatment ] [ Designated as safety issue: Yes ]
  • Chronic lung disease [ Time Frame: Day 28 and corrected age of 36 weeks post-menstrual age ] [ Designated as safety issue: No ]
  • Cystic periventricular leukomalacia at day 28 of life and at term [ Time Frame: Day 28 of life and term corrected age ] [ Designated as safety issue: No ]
  • Retinopathy of prematurity (Worst grade) [ Time Frame: Within hospitalization ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: May 2007
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ibuprofen
Compare ibuprofen
Drug: Ibuprofen
Placebo Comparator: Normal saline
Compared against ibuprofen -- placebo
Drug: Indomethacin

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 29 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Infants <29 weeks gestation with a PDA diameter of >= 1.5 mm on 2Dechocardiogram
  • Parental written informed consent - Parent agrees to the subject's participation in the study as indicated by parent's signature on the consent form
  • Parent is willing to comply with procedures/treatment and is able to keep to scheduled study assessments

Exclusion criteria:

  • Major congenital malformations in the opinion of the investigator
  • Necrotising enterocolitis
  • Gastrointestinal Perforation
  • Systemic illness other than PDA, not fit for the trial in the opinion of the investigator
  • The parent is in the opinion of the investigator, mentally or legally incapacitated
  • The parent is unwilling/unable to comply to study procedures
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00470743

Locations
Singapore
KK Women's and Children's Hospital / National University Hospital
Singapore, Singapore, 229899
Sponsors and Collaborators
KK Women's and Children's Hospital
National University Hospital, Singapore
Cumberland Pharmaceuticals
Investigators
Principal Investigator: Quek Bin Huey, MMed MRCP KK Women's and Children's Hospital
  More Information

No publications provided

Responsible Party: Quek Bin Huey, Consultant, KK Women's and Children's Hospital
ClinicalTrials.gov Identifier: NCT00470743     History of Changes
Other Study ID Numbers: SQPDA02
Study First Received: May 7, 2007
Last Updated: September 1, 2015
Health Authority: Singapore: Health Sciences Authority

Keywords provided by KK Women's and Children's Hospital:
Ibuprofen
Indomethacin
Infant, very low birth weight
Prematurity
Ductus Arteriosus, patent

Additional relevant MeSH terms:
Birth Weight
Ductus Arteriosus, Patent
Body Weight
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities
Heart Defects, Congenital
Heart Diseases
Signs and Symptoms
Ibuprofen
Indomethacin
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Cardiovascular Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Gout Suppressants
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Sensory System Agents
Therapeutic Uses
Tocolytic Agents

ClinicalTrials.gov processed this record on September 02, 2015