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NCT00874393 · ClinicalTrials.gov registry record · Phase 1

Early Blood Pressure Management in Extremely Premature Infants

A Phase 1 study, sponsored by NICHD Neonatal Research Network.

Completed
Registry status
Phase 1
Development phase
10
Enrollment target

NCT00874393 is a Phase 1 study that has completed, run by NICHD Neonatal Research Network. The registered enrollment target is 10 participants.

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The verdict

NCT00874393, a Phase 1 study, has completed, sponsored by NICHD Neonatal Research Network.

COMPLETED
Registry status
Phase 1
Development phase
10 participants
Enrollment target

Study Summary

This trial tests the feasibility of enrolling 60 extremely preterm infants in a randomized, double-blinded study of blood pressure management within 12 months. Eligible infants will receive an infusion drug (dopamine or a dextrose placebo) and a syringe drug (hydrocortisone or a normal saline placebo). Enrolled infants will be randomized to receive one of the following drug pairs: * dopamine and hydrocortisone * dopamine and normal saline * dextrose and hydrocortisone * dextrose and normal saline. In addition to the intervention above, the NRN is conducting a 6-month time-limited prospective observational study of all infants born at an NRN center between 23 and 26 weeks gestational age. All clinical decisions made for these babies will be at the discretion of the attending neonatologist/infant care team according to standard practice at each institution. Data on blood pressure management in the first 24 postnatal hours collected for each infant.

Interventions

  • DRUG Dopamine
  • DRUG Hydrocortisone
  • DRUG Infusion Placebo
  • DRUG Syringe Placebo

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2009-07
Est. Completion 2011-12
Phase Phase 1

Sponsor

NICHD Neonatal Research Network

61 total trials

What the Registry Record Tells You About NCT00874393

The ClinicalTrials.gov registry entry for NCT00874393 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NICHD Neonatal Research Network, which has 61 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which Dopamine is the first listed.

NCT00874393 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00874393 about?

NCT00874393 is a clinical study titled "Early Blood Pressure Management in Extremely Premature Infants". This trial tests the feasibility of enrolling 60 extremely preterm infants in a randomized, double-blinded study of blood pressure management within 12 months. Eligible infants will receive an infusion drug (dopamine or a dextrose placebo) and a syringe drug (hydrocortisone or a normal saline placeb...

What is the current status of trial NCT00874393?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2009-07. Estimated completion is 2011-12.

What interventions are being tested in trial NCT00874393?

The interventions under investigation include: Dopamine (DRUG), Hydrocortisone (DRUG), Infusion Placebo (DRUG), Syringe Placebo (DRUG).

Who is sponsoring clinical trial NCT00874393?

This trial is sponsored by NICHD Neonatal Research Network, which has 61 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.