Early Surfactant Administration at FiO₂ >0.25 Under NIPPV for RDS in Very Preterm Infants
NCT ID: NCT07100652
Last Updated: 2025-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
384 participants
INTERVENTIONAL
2026-01-01
2027-02-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Lower oxygen threshold group (FiO₂ >0.25)
Surfactant was administered as a single initial dose when the fraction of inspired oxygen (FiO₂) exceeded 0.25
Threshold FiO₂
Group 1 (Intervention Group) received the initial dose of pulmonary surfactant immediately upon reaching an inhaled oxygen concentration (FiO₂) \>0.25.
Group 2 (Control Group) received the initial dose of pulmonary surfactant as early as possible within 48 hours, but only when FiO₂ was titrated to \>0.3 based on the infant's clinical condition.
Higer oxygen threshold group (FiO₂ >0.3)
Surfactant was administered as a single initial dose when the fraction of inspired oxygen (FiO₂) exceeded 0.3
Threshold FiO₂
Group 1 (Intervention Group) received the initial dose of pulmonary surfactant immediately upon reaching an inhaled oxygen concentration (FiO₂) \>0.25.
Group 2 (Control Group) received the initial dose of pulmonary surfactant as early as possible within 48 hours, but only when FiO₂ was titrated to \>0.3 based on the infant's clinical condition.
Interventions
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Threshold FiO₂
Group 1 (Intervention Group) received the initial dose of pulmonary surfactant immediately upon reaching an inhaled oxygen concentration (FiO₂) \>0.25.
Group 2 (Control Group) received the initial dose of pulmonary surfactant as early as possible within 48 hours, but only when FiO₂ was titrated to \>0.3 based on the infant's clinical condition.
Eligibility Criteria
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Inclusion Criteria
(3) Admission to NICU within 3 hours of birth. Requirement for non-invasive nasal intermittent positive pressure ventilation (NIPPV) at enrollment.
(4) Signed informed consent obtained from parent(s) or legal guardian(s).
Exclusion Criteria
2. Structural upper airway abnormalities precluding non-invasive ventilation.
3. Confirmed diagnosis of major congenital malformations
4. Endotracheal intubation for indications unrelated to NRDS (e.g., surgery, sepsis management)
5. Initiation of non-invasive ventilation \>3 hours post-birth.
6. Voluntary discharge or treatment withdrawal within 72 hours post-enrollment.
7. Parental/guardian refusal to Sign informed consent or Authorize surfactant administration
8. Incomplete clinical records or missing key outcome variables
\-
3 Hours
ALL
No
Sponsors
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Jiangxi Maternal and Child Health Hospital
OTHER
Jiulongpo No.1 People's Hospital
OTHER
Responsible Party
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Xingwang Zhu
Jiangxi Maternal and Child Health Hospital, Jiangxi, 337000, China
Locations
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Jiangxi Maternal and Child Health Hospital
Nanchang, Jiangxi, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Jiangxi Maternal and Child
Identifier Type: -
Identifier Source: org_study_id
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