Hypotension in Neonates

March 20, 2019 updated by: NICHD Neonatal Research Network

Hydrocortisone Treatment of Hypotension in Term and Late Preterm Infants: An Observational Study

This observational study collects information on the current incidence and management of hypotension in babies born at term or late preterm that are admitted to Neonatal Intensive Care Units (NICUs) within the Neonatal Research Network (NRN). Participants include all newborn infants born at 34 0/7 weeks gestation or greater who are admitted to NICU Network centers and intubated and mechanically ventilated at less than 72 hours of age. The information gathered will provide a framework for the design of a potential randomized controlled trial for the treatment of hypotension in neonates. This observational study is for a time-limited enrollment period of 4-6 months; NRN centers will continue to enroll until at least 50 patients are enrolled per center (for approximately 800-1,000 subjects total).

Study Overview

Status

Completed

Conditions

Detailed Description

An estimated 30-50 percent of infants born at or near term who require ventilation for respiratory failure also receive therapy for hypotension and associated clinical instability, such as poor urine output, poor circulation to the tissues, and metabolic acidosis (a pH imbalance in which the body accumulates too much acid). Emerging evidence, although limited, suggests that the underlying cause of hypotension in many of these infants is that their adrenal glands do not produce adequate amounts of cortisol.

This observational study is to determine the current incidence and management of hypotension in infants born at least 34 0/7 weeks gestation who are intubated and mechanically ventilated at less than 72 hours of age. The goal is to define a target population for a potential randomized controlled trial for the treatment of hypotension in such infants.

In this study, 16 NICHD Neonatal Research Network centers are enrolling at least 50 infants each, collecting basic demographic and baseline data on the mother and baby. In those infants treated for hypotension, data is collected on the dose, duration, and type of therapy, age and blood pressure at the time therapy is started, and the indication for the therapy.

Study Type

Observational

Enrollment (Actual)

820

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Alabama
  - Birmingham, Alabama, United States, 35233
    - University of Alabama at Birmingham
- California
  - Palo Alto, California, United States, 94304
    - Stanford University
- Connecticut
  - New Haven, Connecticut, United States, 06504
    - Yale University
- Georgia
  - Atlanta, Georgia, United States, 30303
    - Emory University
- Indiana
  - Indianapolis, Indiana, United States, 46202
    - Indiana University
- Iowa
  - Iowa City, Iowa, United States, 52242
    - University of Iowa
- Massachusetts
  - Boston, Massachusetts, United States, 02111
    - Tufts Medical Center
- Michigan
  - Detroit, Michigan, United States, 48201
    - Wayne State University
- New Mexico
  - Albuquerque, New Mexico, United States, 87131
    - University of New Mexico
- North Carolina
  - Durham, North Carolina, United States, 27710
    - Duke University
  - Durham, North Carolina, United States, 27705
    - RTI International
- Ohio
  - Cincinnati, Ohio, United States, 45267
    - Cincinnati Children's Medical Center
  - Cleveland, Ohio, United States, 44106
    - Case Western Reserve University
- Rhode Island
  - Providence, Rhode Island, United States, 02905
    - Brown University, Women & Infants Hospital of Rhode Island
- Texas
  - Dallas, Texas, United States, 75235
    - University of Texas Southwestern Medical Center at Dallas
  - Houston, Texas, United States, 77030
    - University of Texas Health Science Center at Houston
- Utah
  - Salt Lake City, Utah, United States, 84108
    - University of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 3 days (Child)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All newborn infants born at ≥34 0/7 weeks gestational age admitted to NICU Network centers who are intubated and mechanically ventilated within 72 hours of postnatal age

Description

Inclusion Criteria:

≥34 0/7 weeks gestational age
Intubated and mechanically ventilated within 72 hours of postnatal age

Exclusion Criteria:

major congenital heart disease
acute hypotension resulting directly from known acute maternal and/or fetal hemorrhage within 24 hours prior to delivery
pituitary hypoplasia
congenital adrenal hyperplasia
known chromosomal disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Prevalence of Hypotension in infants Time Frame: < 72 hours of age until hospital discharge	< 72 hours of age until hospital discharge

Secondary Outcome Measures

Outcome Measure	Time Frame
Management of hypotension in infants Time Frame: < 72 hours of age through resolution of hypotension	< 72 hours of age through resolution of hypotension
Short-term outcomes, including: vasopressor/inotrope exposure, death, time to full nipple feedings, duration of ventilation, and length of NICU stay Time Frame: < 72 hours of age until hospital discharge	< 72 hours of age until hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NICHD Neonatal Research Network

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

National Center for Research Resources (NCRR)

Investigators

Principal Investigator: Michele C Walsh, MD MS, Case Western Reserve University, Rainbow Babies and Children's Hospital
Principal Investigator: Barbara J Stoll, MD, Emory University
Principal Investigator: Ronald N Goldberg, MD, Duke University
Principal Investigator: Richard A Ehrenkranz, MD, Yale University
Principal Investigator: Brenda B Poindexter, MD MS, Indiana University
Principal Investigator: Ivan D Frantz III, MD, Tufts Medical Center
Principal Investigator: Kathleen A Kennedy, MD MPH, The University of Texas Health Science Center, Houston
Principal Investigator: Roger G Faix, MD, University of Utah

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

NICHD Neonatal Research Network

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)