Randomized Controlled Pilot Trial of Budesonide Administration with Surfactant in Very Low Birth Weight Baby with Perinatal Ureaplasma Urealyticum Infection(BABY-UU pilot trial)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2500114316

Enrollment

Unknown

Registered

2025-12-10

Start date

2026-01-01

Completion date

Unknown

Last updated

2025-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perinatal Ureaplasma urealyticum infection

Interventions

Experimental Group:pulmonary surfactant+budesonide

Control group:pulmonary surfactant+Normal Saline (NS)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. The pregnant mother tested positive for UU during this pregnancy before delivery (cervical secretion culture and/or nucleic acid test); 2. Preterm infant born at less than 29 weeks of gestation; 3. Within 12 hours after birth, according to the clinical judgment, the newborn shows clinical indications for surfactant replacement therapy due to 'neonatal respiratory distress syndrome'.

Exclusion criteria

Exclusion criteria: 1. Preterm infants with terminal illness (heart rate <100 beats/min, unresponsive to resuscitation) or deemed by clinicians to have a low chance of survival; 2. Guardians decide to limit or withdraw medical treatment for the preterm infant; 3. The preterm infant has received pulmonary surfactant before enrollment (the first dose of surfactant must be the study drug); 4. The preterm infant has received systemic corticosteroid treatment before enrollment; 5. Severe chromosomal abnormalities or major malformations, severe congenital cardiopulmonary failure; 6. Known congenital infections, including but not limited to confirmed sepsis, congenital cytomegalovirus infection, etc.; 7. Preterm infants with permanent neuromuscular disorders affecting the respiratory system; 8. The preterm infant has already been enrolled in another clinical trial with conflicting interventions.

Design outcomes

Primary

Measure	Time frame
Diagnose with BPD or decease at the PMA 36 weeks;	—

Secondary

Measure	Time frame
severity of BPD;Severe Brain Injury in Cranial Ultrasound;Necrotizing enterocolitis (>Bell II Grade);Patent Ductus Arteriosus Requiring Medical or Surgical Closure;Duration of mechanical ventilation with tracheal intubation;Duration of positive pressure ventilation ;Duration of oxygen use during hospitalization;Discharge with oxygen supply;Hospitalization Duration;Growth Parameters at PMA 36 Weeks : Weight, Length, Head Circumference, and Head-to-Length Ratio;	—

Measure

Time frame

severity of BPD;Severe Brain Injury in Cranial Ultrasound;Necrotizing enterocolitis (>Bell II Grade);Patent Ductus Arteriosus Requiring Medical or Surgical Closure;Duration of mechanical ventilation with tracheal intubation;Duration of positive pressure ventilation ;Duration of oxygen use during hospitalization;Discharge with oxygen supply;Hospitalization Duration;Growth Parameters at PMA 36 Weeks : Weight, Length, Head Circumference, and Head-to-Length Ratio;

—

Countries

China

Contacts

Public ContactZhang Huayan

Guangzhou Women and Children's Medical Center,Guangzhou Medical University

zhangh@chop.edu+86 189 0226 8790

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026