An observational study in Infant, Newborn, Hypotension and Blood Pressure, sponsored by NICHD Neonatal Research Network. Completed at 17 sites in United States. Open to participants aged Up to 72 Hours. Per ClinicalTrials.gov, last updated 2019-03-22.
Sponsored by NICHD Neonatal Research Network · Observational
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).
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.
1,003 studies on the registry are indexed under Hypotension; 173 are open to participants now.
This study's enrollment of 820 is above the median of 84 across 294 observational studies indexed under Hypotension.
Browse Hypotension studies →NICHD Neonatal Research Network is the lead sponsor of 63 studies on the registry; 5 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 7 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
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
Exclusion Criteria:
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
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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NICHD Neonatal Research Network