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

NCT01400737 | Unknown

• 2 other identifiers: 2011-09-ibuprofen2011-09
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Oral Ibuprofen Prophylaxis in Very Low Birth Weight Infants

Keywords

ibuprofen; prophylaxis; VELBW

Outcome Measures

Primary Outcomes (1)

• the effect of oral ibuprofen to prevent hemodynamically significant PDA (hs-PDA) and from rescue therapy

  on the 3rd day of life all subjects will be examined by a experienced pediatric cardiologist and echocardiography will performed to investigate hs-PDA

  in first week of life

Secondary Outcomes (1)

• long term effects of oral ibuprofen prophylaxis in VELBW

  corrected 36 weeks or until discharge

Study Arms (1)

ibuprofen

EXPERIMENTAL

The patients in the control group were given 3 doses of an orange starch suspension as placebo that looked like ibuprofen.

Drug: ibuprofen

Interventions

ibuprofen DRUG

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.

ibuprofen

Eligibility Criteria

• Age: 23 Weeks - 28 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Zekai Tahir Burak Women's Health Research and Education Hospital: lead

Study Sites (1)

Zekai Tahir Burak Maternity Teaching Hospital

Ankara, Turkey (Türkiye)

RECRUITING

Related Publications (2)

• Gokmen T, Erdeve O, Altug N, Oguz SS, Uras N, Dilmen U. Efficacy and safety of oral versus intravenous ibuprofen in very low birth weight preterm infants with patent ductus arteriosus. J Pediatr. 2011 Apr;158(4):549-554.e1. doi: 10.1016/j.jpeds.2010.10.008. Epub 2010 Nov 20.

  PMID: 21094951 BACKGROUND

• Erdeve O, Gokmen T, Altug N, Dilmen U. Oral versus intravenous ibuprofen: which is better in closure of patent ductus arteriosus? Pediatrics. 2009 Apr;123(4):e763. doi: 10.1542/peds.2009-0003. No abstract available.

  PMID: 19336363 BACKGROUND

MeSH Terms

Interventions

Ibuprofen

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Central Study Contacts

H. Gozde Kanmaz, MD

CONTACT

90 505 588 11 89; gzdekanmaz@yahoo.com

Omer Erdeve, MD

CONTACT

omererdeve@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 19, 2011
• First Posted: July 22, 2011
• Study Start: July 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: July 22, 2011

Record last verified: 2011-07

Locations

TU (1)