Oral Ibuprofen Prophylaxis for Patent Ductus Arterioses in Very Extremely Low Birth Weight Infants (OIP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01400737|
Recruitment Status : Unknown
Verified July 2011 by Zekai Tahir Burak Women's Health Research and Education Hospital.
Recruitment status was: Recruiting
First Posted : July 22, 2011
Last Update Posted : July 22, 2011
|Condition or disease||Intervention/treatment||Phase|
|Oral Ibuprofen Prophylaxis in Very Low Birth Weight Infants||Drug: ibuprofen||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Oral Ibuprofen Prophylaxis for Patent Ductus Arterioses in Very Extremely Low Birth Weight Infants|
|Study Start Date :||July 2011|
|Estimated Primary Completion Date :||July 2012|
|Estimated Study Completion Date :||July 2012|
The patients in the control group were given 3 doses of an orange starch suspension as placebo that looked like 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.
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
- the effect of oral ibuprofen to prevent hemodynamically significant PDA (hs-PDA) and from rescue therapy [ Time Frame: in first week of life ]on the 3rd day of life all subjects will be examined by a experienced pediatric cardiologist and echocardiography will performed to investigate hs-PDA
- long term effects of oral ibuprofen prophylaxis in VELBW [ Time Frame: corrected 36 weeks or until discharge ]long term effects such as ROP, BPD,IVH, duration of respiratory support and hospitalization are going to be evaluated.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01400737
|Contact: H. Gozde Kanmaz, MD||90 505 588 11 firstname.lastname@example.org|
|Contact: Omer Erdeve, MDemail@example.com|
|Zekai Tahir Burak Maternity Teaching Hospital||Recruiting|
|Contact: H. Gozde Kanmaz, MD 90 505 588 11 89 firstname.lastname@example.org|
|Contact: Omer Erdeve, MD email@example.com|