Hydrocortisone for Term Hypotension
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01954056 |
|
Recruitment Status :
Completed
First Posted : October 1, 2013
Results First Posted : April 2, 2019
Last Update Posted : July 6, 2021
|
Sponsor:
NICHD Neonatal Research Network
Collaborators:
National Center for Research Resources (NCRR)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
NICHD Neonatal Research Network
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Infant, Newborn, Diseases Cardiovascular Insufficiency | Drug: Hydrocortisone Drug: Placebo | Phase 3 |
Cardiovascular insufficiency is common and potentially life-threatening in critically ill term and late preterm newborns admitted to the newborn intensive care unit (NICU) in the first few days of age.
This study proposes to conduct a multicenter, randomized, masked, placebo-controlled trial within the Neonatal Research Network (NRN). 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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 12 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Hydrocortisone Treatment of Cardiovascular Insufficiency in Term and Late Preterm Infants: A Randomized Controlled Trial |
| Actual Study Start Date : | June 19, 2014 |
| Actual Primary Completion Date : | March 20, 2018 |
| Actual Study Completion Date : | March 20, 2018 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
|
Active Comparator: Hydrocortisone
hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line
|
Drug: Hydrocortisone
• 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line). 1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose |
|
Placebo Comparator: Placebo
Saline placebo
|
Drug: Placebo
7 days of intravenous or intramuscular placebo (normal saline in equal volume) 1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose |
Primary Outcome Measures :
- Death [ Time Frame: Birth to 22-26 months corrected gestational age ]This is measured as Yes if an infant died between birth and 22-26 months corrected gestational age; Otherwise, No.
- Number of Participants With Neurodevelopmental Impairment [ Time Frame: Birth to 22-26 months corrected gestational age ]This is measured as Yes if an any hearing impairment or visual impairment is noted, if non-normal gross motor function level is noted, any seizures have been noted, or if the cognitive, language, or motor scores of the Bayley III score are more than 1 standard deviation below the average; Otherwise, No.
- Number of Participants With Death or Neurodevelopmental Impairment [ Time Frame: Birth to 22-26 months corrected gestational age ]A composite outcome that measures the occurrence of death or neurodevelomental impairment between birth and 22-26 months corrected gestational age.
Secondary Outcome Measures :
- Duration of Mechanical Ventilation [ Time Frame: Birth to 60 days of life ]This is measured as the number of days between birth and 60 days of life of mechanical ventialtion of laryngeal intubation.
- Days to Full Feeds [ Time Frame: Birth to 60 days of life ]The day of life at which full nipple feeds were reached between birth and 60 days of life. Full nipple feeds are defined as at least 120 mg/kg/day.
- Number of Participants With Need for Gastronomy Tube [ Time Frame: Birth to 60 days of life ]This is measured as Yes if a gastronomy tube was placed anytime prior to final status between birth and 60 days of life; Otherwise, No
- Duration of Oxygen Requirement [ Time Frame: Birth to 60 days of life ]This is measured as the number of days between birth and 60 days of life that an infant was on oxygen in the hospital.
- Number of Participants With Need for Home Oxygen [ Time Frame: Birth to 60 days of life ]This is measured as Yes if an infant was discharged to home while on oxygen between birth and 60 days of life; Otherwise, No.
- Hospital Length of Stay [ Time Frame: Birth to 60 days of life ]This is measured as the number of days between birth and 60 days of life that an infant was in the hospital. Infants who died or transferred to another care facility were not included.
- Number of Participants With Renal Insufficiency [ Time Frame: Birth to 60 days of life ]This is measured as Yes if an infant had renal insufficieny between birth and 60 days of life; Otherwise, No. Renal insufficiency is defined as creatinine less than 2 during 7 days after first treatment
- Number of Participants With Necrotizing Enterocolitis [ Time Frame: Birth to 60 days of life ]This is measured as Yes if an infant necrotizing enterocolitis (NEC) between birth and 60 days of life; Otherwise, No. NEC could be proven with or without surgery
- Number of Participants With Need for ECMO Therapy [ Time Frame: Birth to 60 days of life ]This is measured as Yes if an infant received ECMO treatment anytime between birth and 60 days of life; Otherwise, No. Extracorporeal membrane oxygenation (ECMO) is a treatment that uses a pump to circulate blood through an artificial lung back into the bloodstream of a very ill baby.
- Number of Participants With Inotrope Exposure [ Time Frame: 24 hours prior to study drug administration through 3 days post study drug administration. ]This is measured as Yes if an infant was receiving inotropes on the specific day after the initiation of study drug.
- Inotrope Duration [ Time Frame: 24 hours prior to study drug administration through 3 days post study drug administration. ]This is calculated as the number of days on inotropes starting 24 hours prior to initiation of study drug, during the 7-day study drug administration period, and for 3 days after the study drug.
- Maximum Inotrope Dose [ Time Frame: From start of study drug administration (7 days) through 3 days post study drug administration. ]This is calculated as the maximum dose of all inotropes in the 10 days following the initiation of study drug administration. For the purposes of this calculation, dopamine and dobutamine doses were considered equivalent and 0.01 mcg/kg/min of epinephrine was equal to 5 mcg/kg/min of dopamine.
- Oxygenation Index [ Time Frame: Birth to 60 days of life ]This is calculated as fraction of inspired oxygen (FiO2), as a percentage, multiplied by the mean airway pressure divided by partial pressure of oxygen in arterial blood (PaO2), during study drug administration. A lower oxygenation index is better.
- Respiratory Severity [ Time Frame: Birth to 60 days of life ]This is calculated as fraction of inspired oxygen (FiO2), as a percentage, multiplied by the mean airway pressure during study drug administration. Higher score means more severe.
- Number of Participants With Fluid Boluses Given [ Time Frame: Birth to 60 days of life ]This is measured as Yes if an infant received fluid boluses anytime before or during study drug administration between birth and 60 days of life; Otherwise, No.
- Number of Boluses Given [ Time Frame: Birth to 60 days of life ]The number of fluid boluses given per participant, if any, before or during study drug administration between birth and 60 days of life
Information from the National Library of Medicine
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: | 34 Weeks and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
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): NCT01954056
Locations
Show 18 study locations
Sponsors and Collaborators
NICHD Neonatal Research Network
National Center for Research Resources (NCRR)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
| Principal Investigator: | Michele C Walsh, MD | Case Western Reserve University, Rainbow Babies and Children's Hospital | |
| Principal Investigator: | Seetha Shankaran, MD | Wayne State University | |
| Principal Investigator: | Abbot R Laptook, MD | Brown University, Women & Infants Hospital of Rhode Island | |
| Principal Investigator: | Ron 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: | Kurt Schibler, MD | Children's Hospital Medical Center, Cincinnati | |
| Principal Investigator: | Waldemar Carlo, MD | University of Alabama at Birmingham | |
| Principal Investigator: | Edward F Bell, MD | Michele C Walsh, MD Study Principal Investigator Case Western Reserve University, Rainbow Babies and Children's Hospital Seetha Shankaran, MD Study Principal Investigator Wayne State University Abbot R Laptook, MD Study Principal Investigator Brown Un | |
| Study Chair: | Erika Fernandez, MD | University of New Mexico | |
| Principal Investigator: | Myra Wycoff, 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: | Barbara Schmidt, MD | University of Pennsylvania | |
| Principal Investigator: | Carl T D'Angio, MD | University of Rochester | |
| Principal Investigator: | Uday Devaskar, MD | University of California, Los Angeles | |
| Principal Investigator: | Leif Nelin, MD | Research Institute at Nationwide Children's Hospital | |
| Principal Investigator: | William Truog, MD | Children's Mercy Hospital Kansas City |
Study Documents (Full-Text)
Documents provided by NICHD Neonatal Research Network:
Documents provided by NICHD Neonatal Research Network:
Study Protocol and Statistical Analysis Plan [PDF] April 2, 2014
Additional Information:
Keywords provided by NICHD Neonatal Research Network:
|
NICHD Neonatal Research Network Mechanical ventilation Intubation Neurodevelopmental impairment |
Additional relevant MeSH terms:
|
Infant, Newborn, Diseases Hydrocortisone Anti-Inflammatory Agents |