Infant, Newborn, DiseasesPhase 3NCT01954056
Hydrocortisone for Term Hypotension
A Phase 3 study testing Hydrocortisone in people with Infant, Newborn, Diseases and Cardiovascular Insufficiency, run by NICHD Neonatal Research Network at 18 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 34 weeks and older
- Conditions the study is for
- Infant, Newborn, Diseases, Cardiovascular Insufficiency
- What is being tested?
- Hydrocortisone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 18 sitesUnited States
- Study dates
- 19 Jun 2014to 20 Mar 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 34 weeks and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
University of New Mexico
Albuquerque, New Mexico, 87131
Emory University
Atlanta, Georgia, 30303
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Cincinnati Children's Medical Center
Cincinnati, Ohio, 45267
Case Western Reserve University
Cleveland, Ohio, 44106
Research Institute at Nationwide Children's Hospital
Columbus, Ohio, 43205
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75235
Wayne State University
Detroit, Michigan, 48201
RTI International
Durham, North Carolina, 27705
Duke University
Durham, North Carolina, 27710
University of Texas Health Science Center at Houston
Houston, Texas, 77030
Indiana University
Indianapolis, Indiana, 46202
University of Iowa
Iowa City, Iowa, 52242
Children's Mercy Hospital
Kansas City, Missouri, 64108
University of California - Los Angeles
Los Angeles, California, 90025
Stanford University
Palo Alto, California, 94304
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Rochester
Rochester, New York, 14642
About this study
Official title: Hydrocortisone Treatment of Cardiovascular Insufficiency in Term and Late Preterm Infants: A Randomized Controlled Trial
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.
Read the detailed description
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.
- Being tested
- Hydrocortisone, Placebo
- Keywords
- NICHD Neonatal Research Network, Mechanical ventilation, Intubation, Neurodevelopmental impairment
- Medical subject headings
- Infant, Newborn, Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydrocortisoneDrug
- 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
PlaceboDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Hydrocortisone | Active comparator | hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line Receives: Drug: Hydrocortisone |
| Placebo | Placebo comparator | Saline placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
This is measured as Yes if an infant died between birth and 22-26 months corrected gestational age; Otherwise, No.
Measured: Birth to 22-26 months corrected gestational age
Number of Participants With Neurodevelopmental Impairment
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.
Measured: Birth to 22-26 months corrected gestational age
Number of Participants With Death or Neurodevelopmental Impairment
A composite outcome that measures the occurrence of death or neurodevelomental impairment between birth and 22-26 months corrected gestational age.
Measured: Birth to 22-26 months corrected gestational age
Secondary outcomes (16)
Duration of Mechanical Ventilation
This is measured as the number of days between birth and 60 days of life of mechanical ventialtion of laryngeal intubation.
Measured: Birth to 60 days of life
Days to Full Feeds
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.
Measured: Birth to 60 days of life
Number of Participants With Need for Gastronomy Tube
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
Measured: Birth to 60 days of life
Duration of Oxygen Requirement
This is measured as the number of days between birth and 60 days of life that an infant was on oxygen in the hospital.
Measured: Birth to 60 days of life
Number of Participants With Need for Home Oxygen
This is measured as Yes if an infant was discharged to home while on oxygen between birth and 60 days of life; Otherwise, No.
Measured: Birth to 60 days of life
Hospital Length of Stay
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.
Measured: Birth to 60 days of life
Number of Participants With Renal Insufficiency
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
Measured: Birth to 60 days of life
Number of Participants With Necrotizing Enterocolitis
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
Measured: Birth to 60 days of life
Number of Participants With Need for ECMO Therapy
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.
Measured: Birth to 60 days of life
Number of Participants With Inotrope Exposure
This is measured as Yes if an infant was receiving inotropes on the specific day after the initiation of study drug.
Measured: 24 hours prior to study drug administration through 3 days post study drug administration.
Inotrope Duration
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.
Measured: 24 hours prior to study drug administration through 3 days post study drug administration.
Maximum Inotrope Dose
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.
Measured: From start of study drug administration (7 days) through 3 days post study drug administration.
Oxygenation Index
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.
Measured: Birth to 60 days of life
Respiratory Severity
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.
Measured: Birth to 60 days of life
Number of Participants With Fluid Boluses Given
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.
Measured: Birth to 60 days of life
Number of Boluses Given
The number of fluid boluses given per participant, if any, before or during study drug administration between birth and 60 days of life
Measured: Birth to 60 days of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2013 (estimated)
- Study start19 Jun 2014
- Primary completion20 Mar 2018
- Study completion20 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Infant, Newborn, DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- NICHD Neonatal Research Network
- Sponsor type
- Research network
- Collaborators
- National Center for Research Resources (NCRR), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Michele C Walsh, MD, Principal investigator, Case Western Reserve University, Rainbow Babies and Children's HospitalSeetha Shankaran, MD, Principal investigator, Wayne State UniversityAbbot R Laptook, MD, Principal investigator, Brown University, Women & Infants Hospital of Rhode IslandRon N Goldberg, MD, Principal investigator, Duke UniversityBarbara J Stoll, MD, Principal investigator, Emory UniversityBrenda B Poindexter, MD, MS, Principal investigator, Indiana UniversityAbhik Das, PhD, Principal investigator, RTI InternationalKrisa P Van Meurs, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01954056
- Sponsor's protocol ID
- NICHD-NRN-0052
- Other IDs
- U10HD021364, U10HD040689, U10HD021385, U10HD027851, U10HD027853, U10HD027856, U10HD027904, U10HD027880
- Status last verified
- Jul 2021
- First submitted
- 26 Sep 2013
- Last updated
- 6 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hydrocortisone Treatment of Cardiovascular Insufficiency in Term and Late Preterm Infants: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01954056
- Acronym / sponsor ID
- NICHD-NRN-0052
- Keywords
- NICHD Neonatal Research Network, Mechanical ventilation, Intubation, Neurodevelopmental impairment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- NICHD Neonatal Research NetworkResearch network
- Collaborators
- National Center for Research Resources (NCRR), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 19 Jun 2014 (actual)
- Primary completion
- 20 Mar 2018 (actual)
- Study completion
- 20 Mar 2018 (actual)
- First posted
- 1 Oct 2013 (estimated)
- Results
- Posted 2 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydrocortisone | Active comparator | Drug: Hydrocortisonehydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line |
| Placebo | Placebo comparator | Drug: PlaceboSaline placebo |
Who may qualify
- Ages
- 34 weeks and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | Hydrocortisone |
| Placebo7 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 | Drug | Placebo |
Primary outcome
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.
16 secondary outcomes
Duration of Mechanical Ventilation
Time frame: Birth to 60 days of life
Days to Full Feeds
Time frame: Birth to 60 days of life
Number of Participants With Need for Gastronomy Tube
Time frame: Birth to 60 days of life
Duration of Oxygen Requirement
Time frame: Birth to 60 days of life
Number of Participants With Need for Home Oxygen
Time frame: Birth to 60 days of life
Hospital Length of Stay
Time frame: Birth to 60 days of life
Number of Participants With Renal Insufficiency
Time frame: Birth to 60 days of life
Number of Participants With Necrotizing Enterocolitis
Time frame: Birth to 60 days of life
Number of Participants With Need for ECMO Therapy
Time frame: Birth to 60 days of life
Number of Participants With Inotrope Exposure
Time frame: 24 hours prior to study drug administration through 3 days post study drug administration.
Inotrope Duration
Time frame: 24 hours prior to study drug administration through 3 days post study drug administration.
Maximum Inotrope Dose
Time frame: From start of study drug administration (7 days) through 3 days post study drug administration.
Oxygenation Index
Time frame: Birth to 60 days of life
Respiratory Severity
Time frame: Birth to 60 days of life
Number of Participants With Fluid Boluses Given
Time frame: Birth to 60 days of life
Number of Boluses Given
Time frame: Birth to 60 days of life
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- NICHD Neonatal Research Network siteLink provided by the sponsor.
- NICHD Pregnancy \& Perinatology BranchLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michele C Walsh, MD principal investigator
Case Western Reserve University, Rainbow Babies and Children's Hospital
Seetha Shankaran, MD principal investigator
Wayne State University
Abbot R Laptook, MD principal investigator
Brown University, Women & Infants Hospital of Rhode Island
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hydrocortisone in people with Infant, Newborn, Diseases and Cardiovascular Insufficiency, run by NICHD Neonatal Research Network at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death (time frame: Birth to 22-26 months corrected gestational age). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2021.