Respiratory Distress Syndrome (&Amp; [Hyaline Membrane Disease])NCT07100652
Early Surfactant Administration at FiO₂ >0.25 Under NIPPV for RDS in Very Preterm Infants
A study testing Threshold FiO₂ in people with Respiratory Distress Syndrome (&Amp; [Hyaline Membrane Disease]), run by Jiulongpo No.1 People's Hospital at 1 site in China.
Trial summary
This multicenter randomized controlled trial investigates whether initiating pulmonary surfactant (PS) at a lower oxygen threshold (FiO₂ >0.25) during nasal intermittent positive pressure ventilation (NIPPV) for very preterm infants with respiratory distress syndrome (RDS) reduces noninvasive ventilation failure rates… Read more about this study
- Who is it for?
- Ages Up to 3 hours
- Conditions the study is for
- Respiratory Distress Syndrome (&Amp; [Hyaline Membrane Disease])
- What is being tested?
- Threshold FiO₂
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 384 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Up to 3 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- (1) Gestational Age: 26 weeks +0 day to 31 weeks+6days at birth (inclusive). (2) Clinical Diagnosis of NRDS: Symptoms: Tachypnea, grunting, and/or progressive respiratory distress. Imaging Findings: Chest X-ray showing at least one of: Ground-glass opacity, Air bronchograms, Diffuse "white lung" pattern, Lung Ultrasound (recommended).
- Admission to NICU within 3 hours of birth. Requirement for non-invasive nasal intermittent positive pressure ventilation (NIPPV) at enrollment.
- Signed informed consent obtained from parent(s) or legal guardian(s).
Who cannot join
- Invasive mechanical ventilation during delivery or transport to NICU.
- Structural upper airway abnormalities precluding non-invasive ventilation.
- Confirmed diagnosis of major congenital malformations
- Endotracheal intubation for indications unrelated to NRDS (e.g., surgery, sepsis management)
- Initiation of non-invasive ventilation >3 hours post-birth.
- Voluntary discharge or treatment withdrawal within 72 hours post-enrollment.
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- Parental/guardian refusal to Sign informed consent or Authorize surfactant administration
- Incomplete clinical records or missing key outcome variables
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Jiangxi Maternal and Child Health Hospital
Nanchang, Jiangxi
Xingwang Zhu, +86 150843335697, 15084335697@163.com
About this study
Official title: Comparing Different Oxygen Thresholds for Surfactant Administration During Nasal IPPV in Very Preterm Neonates With Respiratory Distress Syndrome: A Superiority RCT
This multicenter randomized controlled trial investigates whether initiating pulmonary surfactant (PS) at a lower oxygen threshold (FiO₂ >0.25) during nasal intermittent positive pressure ventilation (NIPPV) for very preterm infants with respiratory distress syndrome (RDS) reduces noninvasive ventilation failure rates (primary outcome: intubation requirement), compared to the standard threshold (FiO₂ >0.3). By establishing the clinical superiority of early PS administration, this study aims to refine evidence-based guidelines for RDS management in preterm neonates.
- Being tested
- Threshold FiO₂
- Medical subject headings
- Respiratory Distress Syndrome, Hyaline Membrane Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Threshold FiO₂Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Lower oxygen threshold group (FiO₂ >0.25) | Experimental | Surfactant was administered as a single initial dose when the fraction of inspired oxygen (FiO₂) exceeded 0.25 Receives: Procedure: Threshold FiO₂ |
| Higer oxygen threshold group (FiO₂ >0.3) | Active comparator | Surfactant was administered as a single initial dose when the fraction of inspired oxygen (FiO₂) exceeded 0.3 Receives: Procedure: Threshold FiO₂ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-invasive respiratory support failure, defined by the need for IMV within 72 after birth
Measured: 72 hours after birth
Secondary outcomes (13)
The requirement for repeated pulmonary surfactant administration, including the total number of doses utilized
Measured: 7 days after birth
BPD, defined according to the NICHD definition
Measured: 3 months after birth
airleaks occurred after the extubation
Measured: 3 months after birth
retinopathy of prematurity (ROP) > 2nd stage
Measured: 3 months after birth
necrotizing enterocolitis (NEC) ≥ 2nd stage
Measured: 3 months after birth
IVH > 2nd grade
Measured: 3 mionths after birth
hemodynamically significant patent ductus arteriosus (PDA)
Measured: 3 months after birth
weekly weight gain (in grams/d) for the first 4 weeks of life or until NICU discharge, whichever comes first.
Measured: 3 months after birth
Duration of non-invasive respiratory support
Measured: 3 months after birth
total hospitalization cost
Measured: 6 months after birth
nasal skin injury
Measured: 3 months after birth
in-hospital mortality
Measured: 6 months after birth
ventilator-free days
Measured: 3 months after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start1 Jan 2026 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory Distress Syndrome (&Amp; [Hyaline Membrane Disease])Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 384 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiulongpo No.1 People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangxi Maternal and Child Health Hospital
- Responsible party
- Principal investigator, Xingwang Zhu, Jiulongpo No.1 People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07100652
- Sponsor's protocol ID
- Jiangxi Maternal and Child
- Status last verified
- Jul 2025
- First submitted
- 27 Jul 2025
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Yang R, Fang Z, Liu KZ, Zhu X, Ding XP, Luo Q, Zhou WJ, Hu XW, Zhou JL, Tang WY, Shi Y. Comparison of two fractions of inspired oxygen thresholds (0.25 vs 0.30) for surfactant administration in very preterm infants with respiratory distress syndrome under nasal intermittent positive pressure ventilation: study protocol for a multicentre randomised controlled, superiority trial. BMJ Paediatr Open. 2025 Nov 10;9(1):e003998. doi: 10.1136/bmjpo-2025-003998.
PubMed 41213831
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Different Oxygen Thresholds for Surfactant Administration During Nasal IPPV in Very Preterm Neonates With Respiratory Distress Syndrome: A Superiority RCT
- ClinicalTrials.gov ID
- NCT07100652
- Acronym / sponsor ID
- Jiangxi Maternal and Child
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 384 participants (estimated)
- Lead sponsor
- Jiulongpo No.1 People's HospitalUniversity, hospital or other
- Collaborators
- Jiangxi Maternal and Child Health Hospital
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 3 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multicenter randomized controlled trial investigates whether initiating pulmonary surfactant (PS) at a lower oxygen threshold (FiO₂ >0.25) during nasal intermittent positive pressure ventilation (NIPPV) for very preterm infants with respiratory distress syndrome (RDS) reduces noninvasive ventilation failure rates (primary outcome: intubation requirement), compared to the standard threshold (FiO₂ >0.3). By establishing the clinical superiority of early PS administration, this study aims to refine evidence-based guidelines for RDS management in preterm neonates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lower oxygen threshold group (FiO₂ >0.25) | Experimental | Procedure: Threshold FiO₂Surfactant was administered as a single initial dose when the fraction of inspired oxygen (FiO₂) exceeded 0.25 |
| Higer oxygen threshold group (FiO₂ >0.3) | Active comparator | Procedure: Threshold FiO₂Surfactant was administered as a single initial dose when the fraction of inspired oxygen (FiO₂) exceeded 0.3 |
Who may qualify
- Ages
- Up to 3 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- (1) Gestational Age: 26 weeks +0 day to 31 weeks+6days at birth (inclusive). (2) Clinical Diagnosis of NRDS: Symptoms: Tachypnea, grunting, and/or progressive respiratory distress. Imaging Findings: Chest X-ray showing at least one of: Ground-glass opacity, Air bronchograms, Diffuse "white lung" pattern, Lung Ultrasound (recommended).
Key exclusion criteria (9 listed)
- Invasive mechanical ventilation during delivery or transport to NICU.
- Structural upper airway abnormalities precluding non-invasive ventilation.
- Confirmed diagnosis of major congenital malformations
- Endotracheal intubation for indications unrelated to NRDS (e.g., surgery, sepsis management)
- Initiation of non-invasive ventilation >3 hours post-birth.
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 |
|---|---|---|
| Threshold FiO₂Group 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. | Procedure or surgery | Higer oxygen threshold group (FiO₂ >0.3), Lower oxygen threshold group (FiO₂ >0.25) |
Primary outcome
Non-invasive respiratory support failure, defined by the need for IMV within 72 after birth
Time frame: 72 hours after birth
13 secondary outcomes
The requirement for repeated pulmonary surfactant administration, including the total number of doses utilized
Time frame: 7 days after birth
BPD, defined according to the NICHD definition
Time frame: 3 months after birth
airleaks occurred after the extubation
Time frame: 3 months after birth
retinopathy of prematurity (ROP) > 2nd stage
Time frame: 3 months after birth
necrotizing enterocolitis (NEC) ≥ 2nd stage
Time frame: 3 months after birth
IVH > 2nd grade
Time frame: 3 mionths after birth
hemodynamically significant patent ductus arteriosus (PDA)
Time frame: 3 months after birth
weekly weight gain (in grams/d) for the first 4 weeks of life or until NICU discharge, whichever comes first.
Time frame: 3 months after birth
Duration of non-invasive respiratory support
Time frame: 3 months after birth
total hospitalization cost
Time frame: 6 months after birth
nasal skin injury
Time frame: 3 months after birth
in-hospital mortality
Time frame: 6 months after birth
ventilator-free days
Time frame: 3 months after birth
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Derived from this study: PubMed 41213831Yang R, Fang Z, Liu KZ, Zhu X, Ding XP, Luo Q, Zhou WJ, Hu XW, Zhou JL, Tang WY, Shi Y. Comparison of two fractions of inspired oxygen thresholds (0.25 vs 0.30) for surfactant administration in very preterm infants with respiratory distress syndrome under nasal intermittent positive pressure ventilation: study protocol for a multicentre randomised controlled, superiority trial. BMJ Paediatr Open. 2025 Nov 10;9(1):e003998. doi: 10.1136/bmjpo-2025-003998.
- Individual participant dataSharing planned: Yes
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Threshold FiO₂ in people with Respiratory Distress Syndrome (&Amp; [Hyaline Membrane Disease]), run by Jiulongpo No.1 People's Hospital at 1 site in China.
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 9 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: opening soon, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuan Shi, PhD (0791-86224432, shiyuan@hospital.cqmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-invasive respiratory support failure, defined by the need for IMV within 72 after birth (time frame: 72 hours after birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07100652, which also lists 1 linked publication.
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 3 Aug 2025.