Hypotension in Neonates
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| ClinicalTrials.gov Identifier: NCT00882284 |
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Recruitment Status :
Completed
First Posted : April 16, 2009
Last Update Posted : March 22, 2019
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| Condition or disease |
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| Infant, Newborn Hypotension Blood Pressure |
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 |
| Actual Enrollment : | 820 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Hydrocortisone Treatment of Hypotension in Term and Late Preterm Infants: An Observational Study |
| Study Start Date : | April 2009 |
| Actual Primary Completion Date : | December 2009 |
| Actual Study Completion Date : | December 2009 |
- Prevalence of Hypotension in infants [ Time Frame: < 72 hours of age until hospital discharge ]
- Management of hypotension in infants [ Time Frame: < 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 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | up to 72 Hours (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
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): NCT00882284
Show 17 study locations
| Principal Investigator: | Abbot R Laptook, MD | Brown University, Women & Infants Hospital of Rhode Island | |
| Principal Investigator: | Michele C Walsh, MD MS | Case Western Reserve University, Rainbow Babies and Children's Hospital | |
| Principal Investigator: | Ronald N Goldberg, MD | Duke University | |
| Principal Investigator: | Barbara J Stoll, MD | Emory University | |
| Principal Investigator: | Brenda B Poindexter, MD MS | Indiana University | |
| Principal Investigator: | Abhik Das, PhD | RTI International | |
| Principal Investigator: | Krisa P Van Meurs, MD | Stanford University | |
| Principal Investigator: | Ivan D Frantz III, MD | Tufts Medical Center | |
| Principal Investigator: | Kurt Schibler, MD | Children's Hospital Medical Center, Cincinnati | |
| Principal Investigator: | Waldemar A Carlo, MD | University of Alabama at Birmingham | |
| Principal Investigator: | Edward F Bell, MD | University of Iowa | |
| Principal Investigator: | Kristi L Watterberg, MD | University of New Mexico | |
| Principal Investigator: | Pablo J Sanchez, MD | University of Texas, Southwestern Medical Center at Dallas | |
| Principal Investigator: | Kathleen A Kennedy, MD MPH | The University of Texas Health Science Center, Houston | |
| Principal Investigator: | Roger G Faix, MD | University of Utah | |
| Principal Investigator: | Seetha Shankaran, MD | Wayne State University | |
| Principal Investigator: | Richard A Ehrenkranz, MD | Yale University |
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NICHD Neonatal Research Network Blood Pressure Management |
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Hypotension Vascular Diseases Cardiovascular Diseases |