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

NCT01400737 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2011-07-22

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

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

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
23 Weeks
Max Age
28 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • Turkey (Türkiye)

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01400737 on ClinicalTrials.gov