Oral Ibuprofen Prophylaxis for Patent Ductus Arterioses in Very Extremely Low Birth Weight Infants (OIP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Zekai Tahir Burak Women's Health Research and Education Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Zekai Tahir Burak Women's Health Research and Education Hospital
ClinicalTrials.gov Identifier:
NCT01400737
First received: July 19, 2011
Last updated: July 21, 2011
Last verified: July 2011
  Purpose

Patent ductus arterioses (PDA) is a major morbidity in preterm infants, especially in extremely premature infants less than 28 weeks. The clinical signs and symptoms of PDA in preterm infants are non specific and insensitive for making an early diagnosis of significant ductal shunting. Functional echocardiography is emerging as a new valuable bedside tool for early diagnosis of hemodynamically significant ductus, even though there are no universally accepted criteria for grading the hemodynamic significance. Echocardiography has also been used for early targeted treatment of ductus arterioses, though the long term benefits of such strategy are debatable. The biomarkers like BNP and N- terminal pro-BNP are currently under research as diagnostic marker of PDA. The primary mode of treatment for PDA is pharmacological closure using cyclo-oxygenase inhibitors with closure rate of 70-80%. Oral ibuprofen is emerging as a better alternative especially in Indian scenario where parenteral preparations of indomethacin are unavailable and side effects are comparatively lesser. Though pharmacological closure of PDA is an established treatment modality, there is still lack of evidence for long term benefits of such therapy as well as there is some evidence for the possible adverse effects like increased ROP and BPD rates, especially if treated prophylactically.The aim of this study is to investigate the effect of oral ibuprofen prophylaxis administrated on the first 24 hours of life and the following two days on hemodynamically significant patent ductus arterioses and its long term effects such as ROP and BPD.


Condition Intervention
Oral Ibuprofen Prophylaxis in Very Low Birth Weight Infants
Drug: ibuprofen

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Oral Ibuprofen Prophylaxis for Patent Ductus Arterioses in Very Extremely Low Birth Weight Infants

Resource links provided by NLM:


Further study details as provided by Zekai Tahir Burak Women's Health Research and Education Hospital:

Primary Outcome Measures:
  • the effect of oral ibuprofen to prevent hemodynamically significant PDA (hs-PDA) and from rescue therapy [ Time Frame: in first week of life ] [ Designated as safety issue: No ]
    on the 3rd day of life all subjects will be examined by a experienced pediatric cardiologist and echocardiography will performed to investigate hs-PDA


Secondary Outcome Measures:
  • long term effects of oral ibuprofen prophylaxis in VELBW [ Time Frame: corrected 36 weeks or until discharge ] [ Designated as safety issue: Yes ]
    long term effects such as ROP, BPD,IVH, duration of respiratory support and hospitalization are going to be evaluated.


Estimated Enrollment: 200
Study Start Date: July 2011
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ibuprofen
The patients in the control group were given 3 doses of an orange starch suspension as placebo that looked like ibuprofen.
Drug: ibuprofen
The prophylaxis group received ibuprofen suspension at a dosage of 10 mg/kg via an orogastric tube, followed by 0.5 ml of distilled water. The first dose was given within the first 24 hours of life. The second and third doses were given within 24 and 48 hours after the first dose respectively.
Drug: ibuprofen
The prophylaxis group received ibuprofen suspension at a dosage of 10 mg/kg via an orogastric tube, followed by 0.5 ml of distilled water. The first dose was given within the first 24 hours of life. The second and third doses were given within 24 and 48 hours after the first dose respectively

Detailed Description:

Patent ductus arterioses (PDA) is a major morbidity encountered in preterm neonates, especially in babies less than 28 weeks gestation or 1000g.Natural ductal closure is inversely related to gestational age and birth weight. The incidence ranges from 15% to 37% in newborn babies less than 1750 grams.The presence of PDA has significant effects on myocardial functions as well as systemic and pulmonary blood flow. Preterm newborns adapt, by increasing the left ventricular contractility, and thereby maintaining the effective systemic blood flow even when the left to right shunts equals 50% of the left ventricular output. This is mainly accomplished by an increase in stroke volume (SV)rather than heart rate.This increase in stroke volume is primarily due to reduction in afterload and simultaneous increase in left ventricular preload. An increasing number of biological substances like hormones, enzymes which are markers of cardiac stress, dysfunction or myocardial injury-collectively called biomarkers-are emerging as diagnostic and prognostic markers especially in the setting of heart failure or ischemic injury. The pharmacological basis for medical therapy is the use of non selective cyclo-oxygenase (COX) inhibitors, which inhibits prostaglandin synthesis and causes ductal constriction. The two most widely studied and used non selective COX inhibitors are indomethacin and ibuprofen. The future of pharmacological treatment of PDA could be with the use of nitric oxide inhibitors and prostaglandin receptor antagonists. Ibuprofen is an effective choice for the treatment of PDA in preterm infants as it has been demonstrated in previous several studies.Since there is a meta-analysis that claims there is no need for further studies about ibuprofen prophylaxis to treat PDA in low birth weight infants we aimed to evaluate the effect of ibuprofen prophylaxis in very extremely low birth weight infants. One such marker emerging in the diagnosis of hs-PDA is brain natriuretic peptide (BNP). Natriuretic peptides are hormones, produced either by atria (atrial natriuretic peptide-ANP) or by ventricles (BNP) in response to myocardial stress, secondary to dilatation, hypertrophy or increased wall tension.One of the aims of this study is to investigate the effect of oral prophylactic ibuprofen administration on BNP levels and renal functions.

  Eligibility

Ages Eligible for Study:   23 Weeks to 28 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • < 28 gestational week and/or < 1000 g birth weight preterm infants written parent consent

Exclusion Criteria:

  • major congenital anomalies
  • congenital heart diseases
  • not having written parent consent
  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: NCT01400737

Contacts
Contact: H. Gozde Kanmaz, MD 90 505 588 11 89 gzdekanmaz@yahoo.com
Contact: Omer Erdeve, MD omererdeve@yahoo.com

Locations
Turkey
Zekai Tahir Burak Maternity Teaching Hospital Recruiting
Ankara, Turkey
Contact: H. Gozde Kanmaz, MD    90 505 588 11 89    gzdekanmaz@yahoo.com   
Contact: Omer Erdeve, MD       omererdeve@yahoo.com   
Sponsors and Collaborators
Zekai Tahir Burak Women's Health Research and Education Hospital
  More Information

Publications:
Responsible Party: H. Gozde Kanmaz, MD, Fellow of Neonatology, Zekai Tahir Burak Maternity Teaching Hospital, Neonatal Intensive Care Unit
ClinicalTrials.gov Identifier: NCT01400737     History of Changes
Other Study ID Numbers: 2011-09-ibuprofen, 2011-09
Study First Received: July 19, 2011
Last Updated: July 21, 2011
Health Authority: Turkey: Ministry of Health

Keywords provided by Zekai Tahir Burak Women's Health Research and Education Hospital:
ibuprofen
prophylaxis
VELBW

Additional relevant MeSH terms:
Body Weight
Birth Weight
Ductus Arteriosus, Patent
Signs and Symptoms
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Ibuprofen
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

ClinicalTrials.gov processed this record on September 30, 2014