Clinical Trial to Evaluate Two Guidelines for the Administration of Ibuprofen in the Treatment of Persistent Ductus Arteriosus Eco-guided: Impact in the Intestinal Prognosis
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Persistent Ductus Arteriosus
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Administration schedule A: Ibuprofen in continuous iv infusion and EchoG. Each cycle will be 3 doses. Administration schedule B: slow iv bolus Ibuprofen and EchoG. Each cycle will be 3 doses.Masking: Double (Participant, Investigator)Masking Description: A randomized system with closed envelopes will be designed in which patients will be assigned to one of the 2 treatment groups, stratified by gestational age (<28 weeks and ?28 weeks) and by hospital center. In each center and each stratum, they will be randomly assigned in a 1: 1 ratio to each group of study. The assignment will be sequential. The doctors responsible for the patient will be blind to the intervention but will be responsible for the sealed envelopes, and at the time of patient randomization, will deliver the sealed envelope corresponding to the nurses responsible for the preparation of the medication.Primary Purpose: Treatment
Participation Requirements
- Age
- Younger than 33 years
- Gender
- Both males and females
Description
Not Provided
Not Provided
Tracking Information
- NCT #
- NCT04282941
- Collaborators
- Not Provided
- Investigators
- Not Provided
Get Well Soon