Phase 3
N=12
Hydrocortisone for Term Hypotension
Infant, Newborn, Diseases · Cardiovascular Insufficiency
Bottom Line
View on ClinicalTrials.gov: NCT01954056 ↗Enrolled (actual)
12
Serious AEs
8.3%
Results posted
Apr 2019
Primary outcome: Primary: Death — 6; 6; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Hydrocortisone (Drug); Placebo (Drug)
- Age
- Pediatric, Adult, Older Adult · 0+ yrs
- Sex
- All
- Sponsor
- NICHD Neonatal Research Network
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Death |
6; 6; 0; 0 | — |
| PRIMARY Number of Participants With Neurodevelopmental Impairment |
3; 3; 3; 3 | — |
| PRIMARY Number of Participants With Death or Neurodevelopmental Impairment |
3; 3; 3; 3 | — |
| SECONDARY Duration of Mechanical Ventilation |
8; 11 | — |
| SECONDARY Days to Full Feeds |
16; 18 | — |
| SECONDARY Number of Participants With Need for Gastronomy Tube |
6; 6; 0; 0 | — |
| SECONDARY Duration of Oxygen Requirement |
15.5; 18 | — |
| SECONDARY Number of Participants With Need for Home Oxygen |
5; 4; 0; 2 | — |
| SECONDARY Hospital Length of Stay |
27; 24 | — |
| SECONDARY Number of Participants With Renal Insufficiency |
6; 6; 0; 0 | — |
| SECONDARY Number of Participants With Necrotizing Enterocolitis |
5; 6; 1; 0 | — |
| SECONDARY Number of Participants With Need for ECMO Therapy |
6; 6; 0; 0 | — |
| SECONDARY Number of Participants With Inotrope Exposure |
4; 4; 2; 2; 5; 4 | — |
| SECONDARY Inotrope Duration |
3; 3 | — |
| SECONDARY Maximum Inotrope Dose |
9.5; 14.7 | — |
| SECONDARY Oxygenation Index |
10.7; 14.5; 7; 14.9; 6.6; 10.4 | — |
| SECONDARY Respiratory Severity |
726.8; 1184.7; 518.8; 1041.2; 531.6; 925.8 | — |
| SECONDARY Number of Participants With Fluid Boluses Given |
2; 2; 4; 4; 5; 4 | — |
| SECONDARY Number of Boluses Given |
3; 3; 2; 1; 2; 1 | — |
Summary
This trial will evaluate the effects of a 7-day course of hydrocortisone therapy on short-term morbidity, cardiovascular function, long-term neurodevelopment, and mortality in critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age.
Eligibility Criteria
Inclusion Criteria
- Gestational age greater than or equal to 34 weeks at birth
- Admitted to the center NICU by 48 hours of age
- Intubated and mechanically ventilated for a minimum of 2 hours before 72 hours postnatal age
Exclusion Criteria
- Receiving ECMO
- Intubated for the sole purpose of anticipated surgery or airway anomalies
- Treatment will be limited based on poor prognosis
- Receiving dexamethasone or hydrocortisone
- Receiving ibuprofen or indomethacin
- Congenital heart disease
- Hypotension thought to result from specific, immediately remediable factors including placental hemorrhage, acute hemorrhage or tension pneumothorax
- Pituitary hypoplasia or congenital adrenal hyperplasia
- Any chromosomal disorder
- Hypertension in the absence of inotrope therapy as defined by mean arterial blood pressure > 95th percentile
- Initiation of whole body cooling for moderate or severe neonatal encephalopathy
- Brain disorders or any other known structural abnormality
- Major anomalies
Data sourced from ClinicalTrials.gov (NCT01954056). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.