Early Administration of Pulmonary Surfactant Guided by Lung Ultrasound Scores in Very Preterm InfantsNCT06491901
Prospective, Non-Blinded, Randomized Controlled Trial on Early Administration of Pulmonary Surfactant Guided by Lung Ultrasound Scores in Very Preterm Infants.
A study testing PS was given according to lung ultrasound score and PS was given according to clinical criteria in people with Early Administration of Pulmonary Surfactant Guided by Lung Ultrasound Scores in Very Preterm Infants, run by Peking University Third Hospital.
Trial summary
Abstract Background: Bedside lung ultrasonography has been widely used in neonatal intensive care units (NICUs). Lung ultrasound scores (LUS) may predict the need for pulmonary surfactant (PS) application. Read more about this study
- Who is it for?
- Ages 10 minutes to 5 months
- Conditions the study is for
- Early Administration of Pulmonary Surfactant Guided by Lung Ultrasound Scores in Very Preterm Infants
- What is being tested?
- PS was given according to lung ultrasound score and PS was given according to clinical criteria
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2024to 31 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 10 minutes to 5 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants who meet all of the following criteria will be included: (1) very preterm infants with a GA of less than 32 weeks; (2) presence of respiratory distress after birth, such as a respiratory rate of more than 60 breaths/min, grunting, nasal flaring, intercostal retractions, and/or cyanosis; (3) born in the authors' hospital.
Who cannot join
- Infants who meet any of the following criteria will be excluded: (1) infants who have received PS treatment in the delivery room or external setting after birth; (2) infants with known or confirmed congenital abnormalities, especially cardiopulmonary deformities during diagnosis or treatment; (3) presence of severe complications at birth (severe asphyxia, hemorrhagic shock, pneumonia, pneumothorax, early-onset sepsis, and pleural effusion) or other diseases not caused by PS deficiency; (4) infants who die within 72 h after birth, are transferred to another hospital for surgery, or have incomplete data; and (5) those with families who do not consent to participate in this study.
Trial locations and contacts
No sites are listed yet.
About this study
Abstract Background: Bedside lung ultrasonography has been widely used in neonatal intensive care units (NICUs). Lung ultrasound scores (LUS) may predict the need for pulmonary surfactant (PS) application. PS replacement therapy is the key intervention for managing moderate to severe neonatal respiratory distress syndrome (NRDS), with early PS administration playing a positive role in improving patient outcomes. Lung ultrasonography aids in the prompt diagnosis of NRDS, while LUS offers a semi-quantitative assessment of lung health. However, the specific methodologies for utilizing LUS in clinical practice remain controversial. This study hypothesizes that, in very preterm infants (<32 weeks gestational age [GA]) exhibiting respiratory distress symptoms, determining PS application through early postnatal LUS combined with clinical indicators, as opposed to relying solely on clinical signs and chest X-rays, can lead to more timely PS administration, reduce mechanical ventilation duration, improve patient outcomes, and lower the occurrence of bronchopulmonary dysplasia (BPD).
Methods and design: This is a protocol for a prospective, non-blinded, randomized controlled trial that will be conducted in the NICU of a hospital in China. Eligible participants will include very preterm infants (< 32 weeks GA) exhibiting signs of respiratory distress. Infants will be randomly assigned in a 1:1 ratio to either the ultrasound or control group. In the ultrasonography group, the decision regarding PS administration will be based on a combination of lung ultrasonography and clinical manifestations, whereas in the control group, it will be determined solely by clinical signs and chest X-rays. The primary outcome measure will be the mechanical ventilation duration. Statistical analysis will employ independent sample t-tests with a significance level set at α = 0.05 and a power of 80%. The study requires 30 infants per group (in total 60 infants).
Read more
Hypothesis: This study aims to demonstrate that determining PS application based on a combination of LUS and clinical indicators is superior to traditional approaches.
This approach may enhance the accuracy of NRDS diagnosis and facilitate early prediction of PS requirements, thereby reducing the duration of mechanical ventilation. The findings of this research may contribute valuable insights into the use of LUS to guide PS administration.
Read the detailed description
Ultrasound group: Lung ultrasonography will be performed within 1 h of admission, followed by lung ultrasound scoring. If the lung ultrasound confirms RDS and LUS is more than 8, a full dose of PS will be promptly administered at 200 mg/kg (Poractant Alfa, Curosurf®). If the lung ultrasound does not indicate RDS or if LUS is 8 or less, clinical monitoring will continue. Should the clinical criteria for NRDS be met, a full dose of PS will be administered at 200 mg/kg (Poractant Alfa, Curosurf®). Lung ultrasound and scoring will be repeated 4 to 10 h post the first PS dose administration. Repeated PS administration will occur if the criteria are met, with lung ultrasound scoring conducted prior to each administration.
Control group: In cases where clinical diagnosis confirms NRDS, PS will be administered at a dosage of 200 mg/kg (Poractant Alfa, Curosurf®). If clinical manifestations do not meet the diagnosis of NRDS, PS will not be administered.
All enrolled infants will undergo lung ultrasound scoring at 24 h, 3 days, 7 days, 14 days, 28 days, and 36 weeks CA (prior to discharge).
- Being tested
- PS was given according to lung ultrasound score, PS was given according to clinical criteria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PS was given according to lung ultrasound scoreOther
If the lung ultrasound confirms RDS and LUS is more than 8, a full dose of PS will be promptly administered at 200 mg/kg (Poractant Alfa, Curosurf®). If the lung ultrasound does not indicate RDS or if LUS is 8 or less, clinical monitoring will continue. Should the clinical criteria for NRDS be met, a full dose of PS will be administered at 200 mg/kg (Poractant Alfa, Curosurf®). In terms of the administration method, less-invasive surfactant administration (LISA) will be employed for infants in a non-invasive ventilation state, while those in an invasive ventilation state will receive PS via endotracheal tube.
PS was given according to clinical criteriaOther
In cases where clinical diagnosis confirms NRDS, PS will be administered at a dosage of 200 mg/kg (Poractant Alfa, Curosurf®). LISA will be employed for infants in a non-invasive ventilation state, while those in an invasive ventilation state will receive PS via endotracheal tube. If clinical manifestations do not meet the diagnosis of NRDS, PS will not be administered.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound group | Experimental | Lung ultrasonography will be performed within 1 h of admission, followed by lung ultrasound scoring. Receives: Other: PS was given according to lung ultrasound score |
| Control group | Active comparator | NRDS was diagnosed according to clinical criteria. Receives: Other: PS was given according to clinical criteria |
What is being measured
The primary outcome is the main question the study is designed to answer.
the duration of mechanical ventilation
The duration of mechanical ventilation (both invasive and non-invasive) during hospitalization in the ultrasound and control groups.
Measured: At 36 weeks PMA or at discharge, whichever came first
Secondary outcomes (5)
the utilization rate of PS
The utilization rate of PS in both groups
Measured: Within the first week of life
the proportion of infants receiving the first dose of PS early
The proportion of infants receiving the first dose of PS early (within 3 h after birth) and the time from birth to the initial PS administration
Measured: Within the first week of life
the worst oxygenation index (OI)
The worst oxygenation index (OI) at different time points following PS administration
Measured: Within the first week of life
Lung Ultrasound Scores (LUS)
LUS at various intervals following PS administration (at 3 days, 7 days, 14 days, 28 days, and before discharge/at 36 weeks CA)
Measured: At 36 weeks PMA or at discharge, whichever came first
Preterm comorbidities
The incidence rates of major complications in preterm infants such as BPD, intraventricular hemorrhage (IVH), retinopathy of prematurity (ROP), and necrotizing enterocolitis (NEC)
Measured: At 36 weeks PMA or at discharge, whichever came first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start1 Aug 2024 (estimated)
- Primary completion31 May 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Administration of Pulmonary Surfactant Guided by Lung Ultrasound Scores in Very Preterm InfantsStudies 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
- Model description
- A prospective, non-blinded, randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06491901
- Sponsor's protocol ID
- M2023337
- Other IDs
- M22018
- Status last verified
- Jun 2024
- First submitted
- 1 Jul 2024
- Last updated
- 9 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Non-Blinded, Randomized Controlled Trial on Early Administration of Pulmonary Surfactant Guided by Lung Ultrasound Scores in Very Preterm Infants.
- ClinicalTrials.gov ID
- NCT06491901
- Acronym / sponsor ID
- M2023337
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 9 Jul 2024 (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.
Abstract Background: Bedside lung ultrasonography has been widely used in neonatal intensive care units (NICUs). Lung ultrasound scores (LUS) may predict the need for pulmonary surfactant (PS) application. PS replacement therapy is the key intervention for managing moderate to severe neonatal respiratory distress syndrome (NRDS), with early PS administration playing a positive role in improving patient outcomes. Lung ultrasonography aids in the prompt diagnosis of NRDS, while LUS offers a semi-quantitative assessment of lung health. However, the specific methodologies for utilizing LUS in clinical practice remain controversial. This study hypothesizes that, in very preterm infants (<32 weeks gestational age [GA]) exhibiting respiratory distress symptoms, determining PS application through early postnatal LUS combined with clinical indicators, as opposed to relying solely on clinical signs and chest X-rays, can lead to more timely PS administration, reduce mechanical ventilation duration, improve patient outcomes, and lower the occurrence of bronchopulmonary dysplasia (BPD).
Methods and design: This is a protocol for a prospective, non-blinded, randomized controlled trial that will be conducted in the NICU of a hospital in China. Eligible participants will include very preterm infants (< 32 weeks GA) exhibiting signs of respiratory distress. Infants will be randomly assigned in a 1:1 ratio to either the ultrasound or control group. In the ultrasonography group, the decision regarding PS administration will be based on a combination of lung ultrasonography and clinical manifestations, whereas in the control group, it will be determined solely by clinical signs and chest X-rays. The primary outcome measure will be the mechanical ventilation duration. Statistical analysis will employ independent sample t-tests with a significance level set at α = 0.05 and a power of 80%. The study requires 30 infants per group (in total 60 infants).
Hypothesis: This study aims to demonstrate that determining PS application based on a combination of LUS and clinical indicators is superior to traditional approaches.
This approach may enhance the accuracy of NRDS diagnosis and facilitate early prediction of PS requirements, thereby reducing the duration of mechanical ventilation. The findings of this research may contribute valuable insights into the use of LUS to guide PS administration.
Detailed description
Ultrasound group: Lung ultrasonography will be performed within 1 h of admission, followed by lung ultrasound scoring. If the lung ultrasound confirms RDS and LUS is more than 8, a full dose of PS will be promptly administered at 200 mg/kg (Poractant Alfa, Curosurf®). If the lung ultrasound does not indicate RDS or if LUS is 8 or less, clinical monitoring will continue. Should the clinical criteria for NRDS be met, a full dose of PS will be administered at 200 mg/kg (Poractant Alfa, Curosurf®). Lung ultrasound and scoring will be repeated 4 to 10 h post the first PS dose administration. Repeated PS administration will occur if the criteria are met, with lung ultrasound scoring conducted prior to each administration.
Control group: In cases where clinical diagnosis confirms NRDS, PS will be administered at a dosage of 200 mg/kg (Poractant Alfa, Curosurf®). If clinical manifestations do not meet the diagnosis of NRDS, PS will not be administered.
All enrolled infants will undergo lung ultrasound scoring at 24 h, 3 days, 7 days, 14 days, 28 days, and 36 weeks CA (prior to discharge).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A prospective, non-blinded, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Ultrasound group | Experimental | Other: PS was given according to lung ultrasound scoreLung ultrasonography will be performed within 1 h of admission, followed by lung ultrasound scoring. |
| Control group | Active comparator | Other: PS was given according to clinical criteriaNRDS was diagnosed according to clinical criteria. |
Who may qualify
- Ages
- 10 minutes to 5 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Infants who meet all of the following criteria will be included: (1) very preterm infants with a GA of less than 32 weeks; (2) presence of respiratory distress after birth, such as a respiratory rate of more than 60 breaths/min, grunting, nasal flaring, intercostal retractions, and/or cyanosis; (3) born in the authors' hospital.
Key exclusion criteria (1 listed)
- Infants who meet any of the following criteria will be excluded: (1) infants who have received PS treatment in the delivery room or external setting after birth; (2) infants with known or confirmed congenital abnormalities, especially cardiopulmonary deformities during diagnosis or treatment; (3) presence of severe complications at birth (severe asphyxia, hemorrhagic shock, pneumonia, pneumothorax, early-onset sepsis, and pleural effusion) or other diseases not caused by PS deficiency; (4) infants who die within 72 h after birth, are transferred to another hospital for surgery, or have incomplete data; and (5) those with families who do not consent to participate in this study.
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 |
|---|---|---|
| PS was given according to lung ultrasound scoreIf the lung ultrasound confirms RDS and LUS is more than 8, a full dose of PS will be promptly administered at 200 mg/kg (Poractant Alfa, Curosurf®). If the lung ultrasound does not indicate RDS or if LUS is 8 or less, clinical monitoring will continue. Should the clinical criteria for NRDS be met, a full dose of PS will be administered at 200 mg/kg (Poractant Alfa, Curosurf®). In terms of the administration method, less-invasive surfactant administration (LISA) will be employed for infants in a non-invasive ventilation state, while those in an invasive ventilation state will receive PS via endotracheal tube. | Other | Ultrasound group |
| PS was given according to clinical criteriaIn cases where clinical diagnosis confirms NRDS, PS will be administered at a dosage of 200 mg/kg (Poractant Alfa, Curosurf®). LISA will be employed for infants in a non-invasive ventilation state, while those in an invasive ventilation state will receive PS via endotracheal tube. If clinical manifestations do not meet the diagnosis of NRDS, PS will not be administered. | Other | Control group |
Primary outcome
the duration of mechanical ventilation
Time frame: At 36 weeks PMA or at discharge, whichever came first
The duration of mechanical ventilation (both invasive and non-invasive) during hospitalization in the ultrasound and control groups.
5 secondary outcomes
the utilization rate of PS
Time frame: Within the first week of life
the proportion of infants receiving the first dose of PS early
Time frame: Within the first week of life
the worst oxygenation index (OI)
Time frame: Within the first week of life
Lung Ultrasound Scores (LUS)
Time frame: At 36 weeks PMA or at discharge, whichever came first
Preterm comorbidities
Time frame: At 36 weeks PMA or at discharge, whichever came first
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
- Individual participant dataSharing planned: Undecided
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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing PS was given according to lung ultrasound score and PS was given according to clinical criteria in people with Early Administration of Pulmonary Surfactant Guided by Lung Ultrasound Scores in Very Preterm Infants, run by Peking University Third Hospital.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 9 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhang Jinghui (15110262849, penguin_post@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the duration of mechanical ventilation (time frame: At 36 weeks PMA or at discharge, whichever came first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jul 2024.