Table 3. Detailed analysis of randomized-controlled trials evaluating steroids in neonates.
| N | Start / End of study (years) * | Title / Primary outcome / Long-term follow-up | Trial status** Study Chair (SC) or Principal Investigator (PI) (Publications) |
|---|---|---|---|
| RCT hydrocortisone versus placebo | |||
| 1 | 2001/2005 Prevention trial NCT00004669 |
Phase II Pilot Study of Early Cortisol Replacement to Prevent Bronchopulmonary Dysplasia PO: Estimate (versus placebo) the efficacy of cortisol replacement therapy during the first 12 days of life for prevention of bronchopulmonary dysplasia. LT: no |
Completed SC: KL Watterberg [20] |
| 2 | 2005/2015 Prevention trial lNCT00167544 |
Randomized Trial of Hydrocortisone in Very Preterm High-Risk Infants PO: Total Cerebral Volume as Measured by Volumetric Brain MRI LT: no |
Completed PI: NA Parikh [21] |
| 3 | 2006/2011 Treatment trial NCT00358748 |
Early Use of Hydrocortisone in Hypotensive Very Low Birth Weight Infants. PO: Total cumulative dose of dopamine at 48 hours of study drug administration and by day 7 of life in neonates with gestational age ≤ 30 weeks LT: no |
Completed PI: H Osiovich [22] |
| 4 | 2007/2013 Treatment trial NCT00590018 |
Corticosteroids (hydrocortisone) in postoperative critically ill Neonates With Low Cardiac Output syndrome With Congenital Heart Disease PO: HR, BP, mVO2 to assess cardiac output in patients aged <1month LT: no |
Completed PI: HA Dickerson |
| 5 | 2008/2016 Prevention trial NCT 00623740 |
PREMILOC: Trial to Prevent Bronchopulmonary Dysplasia in Very Preterm Neonates PO: survival without BPD at 36 weeks PMA gestational age, in neonates between 24 weeks and 27 weeks + 6 days gestational age LT: neurodevelopmental outcome at 18 months to 3 years |
Completed PI: O Baud [23] |
| 6 | 2014/2018 Treatment trial NCT01954056 |
Hydrocortisone for Term Hypotension PO: Death or neurodevelopmental impairment 34 Weeks’ gestational age and older LT: Neurodevelopmental Impairment [Birth to 22–26 month corrected age] |
Active—Not recruiting SC: E.Fernandez |
| RCT Budesonide versus placebo | |||
| 7 | 2009/ 2013 Prevention trial NCT00883532 |
Prevention of Chronic Lung Disease (CLD) in Preterm Infants PO: Chronic lung disease morbidity among the survival at 36 postconceptional weeks LT: Neurodevelopment at 2 years of age |
Completed PI: TF Yeh [24] |
| 8 | 2010 /2016 Treatment trial NCT01035190 |
Efficacy and Safety of Inhaled Budesonide in Very Preterm Infants at Risk for Bronchopulmonary Dysplasia PO: To determine whether inhalation of Budesonide within 12 hours of life improves survival without BPD at 36 weeks GA in infants born between 23 and 27 weeks GA LT: neurodevelopment at a corrected age of 18–22 months |
Completed PI: D Bassler [25] |
| 10 | 2012 / 2015 Treatment trial NCT01858129 |
Inhaled Corticosteroids for the Treatment of Transient Tachypnea (TTN) of the Newborn PO: assessment of respiratory distress at 48 hours, reflected by TTN clinical score in Infants Born at >34 Weeks Gestation LT: no |
Recruiting PI: A Kugelman |
| 9 | 2016 / 2018 Prevention trial NCT01895075 |
Inhaled budesonide in non-ventilated infants at high risk of bronchopulmonary dysplasia: the i-BUD pilot study. PO: Total days on supplemental oxygen from birth to discharge LT: no |
Not yet recruiting PI: M Dunn |
| RCT of other corticosteroids versus placebo | |||
| 11 | 1992 / 1994 Treatment trial NCT00011362 |
Dexamethasone Therapy in VLBW Infants at Risk of CLD PO: Number of days from randomization to ventilator independence LT: Morbidity and mortality from respiratory causes during the first year (12 months of age) |
Completed PI: LA Papille [26] |
| 12 | 1993/1999 Prevention trial NCT00000576 |
Inhaled Beclomethasone to Prevent Chronic Lung Disease PO: bronchopulmonary dysplasia at 28 days of age in premature infants (birth weight less than 1251 grams, gestational age less than 33 weeks, and postnatal age 3 to f14 days, under mechanical ventilation LT: no |
Completed [27] |
| 13 | 2014/2017 Treatment trial NCT01757899 |
Effects and Safety of Infusion of Low-Doses of Methylprednisolone in Early ALI and ARDS (Acute Lung Injury and Acute Respiratory Distress Syndrome) in patients up to 17 Years (PEDALI) PO: Effects on pulmonary organ function at 24 months of entry LT: Complications at 12 months of entry (safety issue) |
Recruiting SC: MCM Barbosa |
* estimated year,
** Definitions as provided in Clinicaltrial.gov: Completed: "last subject, last visit" has occurred, Terminated: the clinical study has stopped recruiting or enrolling participants early and will not start again, Participants are no longer being examined or treated.
PO: Primary Objective, LO: Long-term, PI: Principal Investigator, SC: Study Chair