bronchopulmonary dysplasia
Conditions
Interventions
hydrocortisone:Intravenous administration of hydrocortisone within 24 hours after birth.
placebo:An equal amount of physiological saline was administered intravenously within 24 hours after birth.
Sponsors
Shenzhen Maternity & Child Healthcare Hospital
Eligibility
Sex/Gender
All
Age
0.4 Years to 2.2 Years
Inclusion criteria
Inclusion criteria: 1.Gestational age less than 26 weeks 2.Parental consent had been obtained
Exclusion criteria
Exclusion criteria: 1.Congenital malformations affecting pulmonary function (e.g., congenital surfactant protein deficiencies, congenital diaphragmatic hernia,Pierre Robin Syndrome ,Chromosomal defects (e.g., trisomy 13, 18, 21). 2.Parents refuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| survival without moderate or severe bronchopulmonary dysplasia; | — |
Secondary
| Measure | Time frame |
|---|---|
| Failure to extubate at days14, 21 and 28;Total duration of mechanical ventilation and supplemental oxygen;Need for late rescue treatment with dexamethasone;Use of "rescue treatment" with hydrocortisone outside the study protocol;Types, dosages, and durations of vasoactive drugs used within 14 days after birth;Intraventricular hemorrhage > =grade ? and/ or periventricular leucomalacia;Nosocomial infection, including cultured proven sepsis, meningitis, and pneumonia. Culture-proven infection is defined as a positive culture obtained from sputum, urine, blood, or cerebrospinal fluid of infants with clinical signs of infection, and pneumonia will be confirmed by abnormal lung examination (such X-ray, CT);Neonatal necrotizing enterocolitis ;Spontaneous intestinal perforation;Hemodynamic significant patent ductus arteriosus for which medical intervention or surgical ligation is needed;Retinopathy of prematurity (ROP);Anthropometric indices. Body length, head circumference, and body weight at 28 postnatal days ,36 weeks of PMA ,40 weeks PMA and at discharge;Blood pressure fluctuations within 14 days after birth;Metabolic disorders occur within 14 days after birth;Hospitalization days; | — |
Countries
China
Contacts
Public ContactYang Chuan Zhong
Department of Neonatology, Shenzhen Maternity & Child Healthcare Hospital,GuangGong Province ,China
Outcome results
None listed