Comparing Ibuprofen And Indomethacin For The Treatment Of The Patent Ductus Arteriosus in Very Premature Babies - Full Text View

Sponsor:	KK Women's and Children's Hospital
Collaborators:	National University Hospital, Singapore Cumberland Pharmaceuticals
Information provided by:	KK Women's and Children's Hospital
ClinicalTrials.gov Identifier:	NCT00470743

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 Prematurity	Drug: Ibuprofen and Indomethacin	Phase IV

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:

MedlinePlus related topics: High Blood Pressure Premature Babies

Drug Information available for: Indomethacin Ibuprofen

U.S. FDA Resources

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 ]

Secondary Outcome Measures:

PDA closure rates after medical treatment at time of discharge from hospital [ Time Frame: after 1 to 2 courses of treatment ]
Need for repeat of the second course of medication [ Time Frame: 48 hrs after 3rd dose of treatment ]
Need for surgical closure [ Time Frame: after 1 to 2 courses of treatment ]
In-hospital mortality [ Time Frame: while in-hospital ]
Creatinine >140umol/L within one week after the 1st dose of treatment [ Time Frame: one week after 1st dose of treatment ]
Hyponatremia within one week after the 1st dose of treatment [ Time Frame: one week after 1st dose of treatment ]
Gastrointestinal perforation within one week after the 1st dose of treatment [ Time Frame: within one week after the 1st dose of treatment ]
Necrotising enterocolitis within one week after the 1st dose of treatment [ Time Frame: within one week after the 1st dose of treatment ]
Worst grade of IVH by Day 28 of life [ Time Frame: Day 28 of life ]
Pulmonary hypertension within 48hrs after 1st dose of treatment [ Time Frame: within 48hrs after 1st dose of treatment ]
Chronic lung disease [ Time Frame: Day 28 and corrected age of 36 weeks post-menstrual age ]
Cystic periventricular leukomalacia at day 28 of life and at term [ Time Frame: Day 28 of life and term corrected age ]
Retinopathy of prematurity (Worst grade) [ Time Frame: Within hospitalization ]

Estimated Enrollment:	150
Study Start Date:	May 2007
Estimated Study Completion Date:	June 2009

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

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

ClinicalTrials.gov Identifier:	NCT00470743 History of Changes
Other Study ID Numbers:	SQPDA02
Study First Received:	May 7, 2007
Last Updated:	June 23, 2009
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:

Ductus Arteriosus, Patent
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Ibuprofen
Indomethacin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Gout Suppressants
Tocolytic Agents
Reproductive Control Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on February 09, 2012