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NRDSNCT07092319

Impact of Delayed Cord Clamping and Minimally Invasive Surfactant Administration on Outcomes in Premature Infants Less Than 30 Weeks Gestation

An observational study of NRDS, run by Peking University Third Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Background: Preventing early exposure to invasive mechanical ventilation in premature infants is crucial for reducing the incidence of bronchopulmonary dysplasia (BPD) and improving overall outcomes. Read more about this study

Who is it for?
Any age
Conditions the study is for
NRDS
What is being tested?
deferred cord clamping
Type of treatment
Surgery or procedure
How many people
518 participants
Where
1 siteChina
Study dates
30 Aug 2025to 31 Oct 2027
Phase
Observational
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: This study is a single-center ambispective cohort study involving hospitalized preterm infants in the NICU of Peking University Third Hospital from June 1st, 2017, to May 31th, 2025. The subjects from June 1st, 2017, to May 31 th, 2024, were included in the retrospective cohort study, while a prospective cohort study was conducted from June 1st , 2024, to May 31th, 2025.

Who may be able to join

None listed.

Who cannot join

  • Premature infants who have received tracheal intubation prior to the use of PS due to resuscitation or other reasons shortly after birth; ② Premature infants with identified or confirmed congenital abnormalities (such as fetal edema, chylothorax, or neuromuscular disease) or severe birth complications (including hemorrhagic shock, air leakage, or early-onset sepsis) that impact respiratory function.; ③ Newborns who discontinue treatment or have incomplete information; ④ Newborns involved in other intervention research studies.

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
  • Peking University Third Hospital

    Beijing

    Tongyan Han, +8615611963386, tongyanhan@bjmu.edu.cn

Other trials in China

About this study

Official title: Impact of Delayed Cord Clamping and Minimally Invasive Surfactant Administration on Outcomes in Premature Infants With Neonatal Respiratory Distress Syndrome at Less Than 30 Weeks Gestation: A NICU Quality Improvement Study

Background:

Preventing early exposure to invasive mechanical ventilation in premature infants is crucial for reducing the incidence of bronchopulmonary dysplasia (BPD) and improving overall outcomes. Compared to immediate cord clamping (ICC) and tracheal intubation for pulmonary surfactant administration at birth, delayed cord clamping (DCC) combined with minimally invasive surfactant administration (MISA) has been shown to enhance early respiratory and circulatory stability in premature infants, thereby decreasing the need for invasive mechanical ventilation. The investigators hypothesize that for preterm infants under 30 weeks gestation diagnosed with respiratory distress syndrome (RDS), the combination of DCC and MISA will more effectively reduce the incidence of BPD.

Read more

Methods and Design:

The investigators will conduct a single-center ambispective cohort study to compare three treatment regimens in premature infants diagnosed with neonatal respiratory distress syndrome (NRDS) at less than 30 weeks gestation: Delayed cord clamping (DCC) combined with minimally invasive surfactant administration (MISA) (n=74); Immediate cord clamping (ICC) combined with tracheal intubation for pulmonary surfactant administration (n=222); Immediate cord clamping (ICC) combined with MISA (n=222). The study aims to evaluate the incidence of bronchopulmonary dysplasia (BPD), short-term treatment effects, safety, and long-term outcomes associated with each regimen, providing valuable evidence for clinical treatment decisions.

Discussion:

Current research indicates that both delayed cord clamping (DCC) and minimally invasive surfactant administration (MISA) positively impact the prognosis of very premature infants and help reduce the incidence of bronchopulmonary dysplasia (BPD). However, there is limited research on whether the combined use of DCC and MISA can further enhance survival rates and decrease BPD incidence in this vulnerable population.

The investigators NICU has gradually implemented MISA in respiratory management since 2017 and adopted cord management with DCC since 2023. This study retrospectively analyzes data from previous groups: those receiving immediate cord clamping (ICC) with MISA, and those receiving ICC with tracheal intubation. The investigators will compare this with prospective data from the DCC combined with MISA group to assess differences in BPD occurrence, other complications and overall outcomes.

Through this study, the investigators aim to determine whether the combination of DCC and MISA offers greater benefits in improving the prognosis of very premature infants, ultimately providing a stronger foundation for early respiratory and circulatory management strategies for infants born before 30 weeks.

Read the detailed description

With the rapid advancement of neonatal intensive care technology, the survival rate of premature infants born at less than 30 weeks gestation continues to rise. However, the immaturity of various organ systems leads to a high incidence of complications, and long-term outcomes can often be less than optimistic[1]. Consequently, enhancing both short-term and long-term prognoses for these infants through quality improvement initiatives has become a prominent focus in recent clinical research.

Bronchopulmonary dysplasia (BPD) is a critical complication in very premature infants, significantly affecting their future survival, as well as their respiratory and neurological development. Preventing and reducing the incidence of BPD is crucial for improving the overall prognosis of these infants[2]. Ensuring postpartum respiratory and circulatory stability while minimizing exposure to early invasive mechanical ventilation is essential for preventing and reducing the incidence of BPD.

The management of respiratory and circulatory conditions in preterm infants begins with delayed umbilical cord clamping (DCC) in the delivery room. Compared to immediate cord clamping (ICC), DCC facilitates the transfer of blood from the placenta to the infant, enhancing the adaptability of vital organs such as the heart, brain, and lungs. This practice supports a smoother transition from intrauterine to extrauterine life, promotes the conversion of respiratory circulation, and can reduce preterm infant mortality by 30%. Additionally, DCC decreases the incidence of complications such as intraventricular hemorrhage, necrotizing enterocolitis, and late-onset sepsis. It also increases blood volume, minimizes the need for blood transfusions, enhances iron storage, and lowers the risk of long-term neurodevelopmental issues. Therefore, DCC emerges as a viable strategy to enhance the perinatal prognosis of preterm infants[4-8]. However, there are limited reports in China regarding the implementation of DCC in premature infants born at less than 30 weeks gestation. The investigators hospital began adopting DCC for preterm infants in 2023 and has developed and standardized the operational procedures for this practice. However, relevant clinical studies have yet to be conducted.

Neonatal respiratory distress syndrome (NRDS) is a condition resulting from a deficiency of pulmonary surfactant (PS) in the alveoli. It is the most common respiratory issue encountered by very premature infants, who often experience progressively worsening respiratory distress shortly after birth. Treatment for NRDS involves respiratory support and the administration of exogenous PS. Traditionally, this is done through tracheal intubation. However, recent clinical studies have demonstrated that minimally invasive surfactant administration (MISA) offers several advantages over tracheal intubation. MISA effectively reduces the need for invasive mechanical ventilation within the first 72 hours and plays a significant role in lowering the incidence of bronchopulmonary dysplasia (BPD)[9].

With advancements in DCC and MISA technology in NICU settings, these approaches have become the preferred options for very premature infants who are breathing spontaneously at birth. To further assess the safety and effectiveness of DCC combined with MISA in the investigators hospital's NICU for premature infants born at less than 30 weeks gestation, the investigators propose this quality improvement study. The study aims to compare the incidence and prognosis of bronchopulmonary dysplasia (BPD) and other complications before and after the implementation of DCC and MISA in the NICU.

The investigators hospital has been implementing MISA since 2017 and has gained extensive clinical experience in treating NRDS in premature infants using this method. The investigators previously conducted a prospective multicenter study comparing MISA with tracheal intubation for surfactant administration shortly after birth. The results indicated that the incidence of bronchopulmonary dysplasia (BPD) and hemodynamically significant patent ductus arteriosus (hsPDA) was lower in the MISA group, highlighting its suitability for premature infants born at less than 30 weeks gestation[10-11]. The investigators hospital has gradually implemented DCC for premature infants prior to this research and has established a comprehensive protocol for its application in the delivery room and during surgical procedures. As a result, the investigators NICU is well-equipped to perform DCC combined with MISA for infants born at less than 30 weeks gestation. Based on previous research findings, this study specifically targets premature infants under 30 weeks, a group that exhibits a relatively high incidence of bronchopulmonary dysplasia (BPD). By monitoring the respiratory and overall health outcomes of these infants following the application of DCC combined with MISA, the investigators aim to evaluate the effectiveness of this NICU quality improvement measure in enhancing the prognosis of very premature infants.

Conditions
NRDS
Being tested
deferred cord clamping
Keywords
Delayed cord clamping, minimally invasive surfactant administration, preterm infants

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • deferred cord clampingProcedure or surgery

    Also called minimally invasive surfactant administration

    DCC: deferred cord clamping successfully for 60 seconds;MISA: Surfactant administration by minimally invasive methods that allow for spontaneous breathing.

Study groups in NCT07092319
Study groupRoleWhat they receive
DCC+MISA groupInfants without contraindications to DCC, as determined by prenatal evaluation, receive immediate non-invasive respiratory support after birth. DCC is successfully performed for 60 seconds, followed by a diagnosis of NRDS. A therapeutic dose of pulmonary surfactant (PS) is administered via MISA within the first 2 hours after birth.
Receives: Procedure: deferred cord clamping
ICC+tracheal intubation groupUmbilical cord clamping occurs within 20 seconds after birth. Infants are diagnosed with NRDS and receive a therapeutic dose of PS via tracheal intubation within the first 12 hours after birth.
ICC+MISA groupUmbilical cord clamping is performed within 20 seconds after birth. Infants are diagnosed with NRDS and receive a therapeutic dose of PS via MISA within the first 2 hours after birth.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. incidence of bronchopulmonary dysplasia

    The primary outcome is the incidence of bronchopulmonary dysplasia (BPD) at a corrected gestational age of 36 weeks.

    Measured: At 36 weeks PMA

Secondary outcomes (10)
  1. Rate of patent ductus arteriosus with hemodynamic changes

    Rate of patent ductus arteriosus with hemodynamic changes

    Measured: From enrollment to 30 days after birth

  2. Rate of air leakage, pulmonary hemorrhage, infectious pneumonia

    Rate of air leakage, pulmonary hemorrhage, infectious pneumonia

    Measured: Through study completion and up to corrected three months

  3. Rate of late onset sepsis with positive blood culture

    Rate of late onset sepsis with positive blood culture

    Measured: Through study completion and up to corrected three months

  4. Rate of retinopathy of prematurity

    Rate of retinopathy of prematurity onset before correcting gestational age for 50 weeks

    Measured: Through study completion and up to corrected three months

  5. Rate of III-IV ° periventricular intraventricular hemorrhage and periventricular leukomalacia

    Rate of III-IV ° periventricular intraventricular hemorrhage and periventricular leukomalacia

    Measured: Through study completion and up to corrected three months

  6. Rate of neonatal necrotizing enterocolitis IIa or above

    Rate of neonatal necrotizing enterocolitis IIa or above

    Measured: Through study completion and up to corrected three months

  7. Length of hospital stay

    Length of hospital stay

    Measured: From enrollment to the end of treatment at an average of 8 weeks

  8. In-hospital mortality

    In-hospital mortality

    Measured: Through study completion and up to corrected three months

  9. Rate of hyperbilirubinemia

    Rate of hyperbilirubinemia

    Measured: Through study completion and up to corrected three months

  10. First time of blood transfusion during hospitalization

    First time of blood transfusion during hospitalization

    Measured: Through study completion and up to corrected three months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2025
  2. Study start30 Aug 2025 (estimated)
  3. Primary completion30 Aug 2027 (estimated)
  4. Study completion31 Oct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
518 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07092319
Sponsor's protocol ID
M2024376
Status last verified
Jul 2025
First submitted
28 May 2024
Last updated
29 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Fogarty M, Osborn DA, Askie L, Seidler AL, Hunter K, Lui K, Simes J, Tarnow-Mordi W. Delayed vs early umbilical cord clamping for preterm infants: a systematic review and meta-analysis. Am J Obstet Gynecol. 2018 Jan;218(1):1-18. doi: 10.1016/j.ajog.2017.10.231. Epub 2017 Oct 30.

    PubMed 29097178
  • Garcia C, Prieto MT, Escudero F, Bosh-Gimenez V, Quesada L, Lewanczyk M, Pertegal M, Delgado JL, Blanco-Carnero JE, De Paco Matallana C. The impact of early versus delayed cord clamping on hematological and cardiovascular changes in preterm newborns between 24 and 34 weeks' gestation: a randomized clinical trial. Arch Gynecol Obstet. 2024 Jun;309(6):2483-2490. doi: 10.1007/s00404-023-07119-0. Epub 2023 Jul 12.

    PubMed 37436461
  • Yoon S, Jin Y, Kim Y, Sung JH, Choi SJ, Oh SY, Roh CR. Effect of delayed cord clamping on maternal and neonatal outcome in twin pregnancies: a retrospective cohort study. Sci Rep. 2023 Oct 13;13(1):17339. doi: 10.1038/s41598-023-44575-9.

    PubMed 37833351
  • McDonald SD. Deferred cord clamping and cord milking: Certainty and quality of the evidence in meta-analyses, and systematic reviews of randomized control trials, guidelines, and implementation studies. Semin Perinatol. 2023 Aug;47(5):151790. doi: 10.1016/j.semperi.2023.151790. Epub 2023 Jun 13.

    PubMed 37349189
  • McDonald SD, Narvey M, Ehman W, Jain V, Cassell K. Guideline No. 424: Umbilical Cord Management in Preterm and Term Infants. J Obstet Gynaecol Can. 2022 Mar;44(3):313-322.e1. doi: 10.1016/j.jogc.2022.01.007.

    PubMed 35300830
  • Jobe AH. Mechanisms of Lung Injury and Bronchopulmonary Dysplasia. Am J Perinatol. 2016 Sep;33(11):1076-8. doi: 10.1055/s-0036-1586107. Epub 2016 Sep 7.

    PubMed 27603539
  • Doyle LW, Carse E, Adams AM, Ranganathan S, Opie G, Cheong JLY; Victorian Infant Collaborative Study Group. Ventilation in Extremely Preterm Infants and Respiratory Function at 8 Years. N Engl J Med. 2017 Jul 27;377(4):329-337. doi: 10.1056/NEJMoa1700827.

    PubMed 28745986
  • Lui K, Lee SK, Kusuda S, Adams M, Vento M, Reichman B, Darlow BA, Lehtonen L, Modi N, Norman M, Hakansson S, Bassler D, Rusconi F, Lodha A, Yang J, Shah PS; International Network for Evaluation of Outcomes (iNeo) of neonates Investigators. Trends in Outcomes for Neonates Born Very Preterm and Very Low Birth Weight in 11 High-Income Countries. J Pediatr. 2019 Dec;215:32-40.e14. doi: 10.1016/j.jpeds.2019.08.020. Epub 2019 Oct 3.

    PubMed 31587861
  • Zhang Y, Zhang H, Zhang Y, Li X, Yan Z, Zhang J, Zhang H, Piao M, Han T. Impact of delayed cord clamping and minimally invasive surfactant administration on outcomes in premature infants with neonatal respiratory distress syndrome at less than 30 weeks gestation: a NICU quality improvement study. Front Pediatr. 2025 Nov 18;13:1686362. doi: 10.3389/fped.2025.1686362. eCollection 2025.

    PubMed 41341102

Questions about this trial

What is this clinical trial studying?

An observational study of NRDS, run by Peking University Third 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 0 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: opening soon, as of the sponsor's last update on 29 Jul 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 Tongyan Han (+8615611963386, tongyanhan@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

incidence of bronchopulmonary dysplasia (time frame: At 36 weeks PMA). 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 NCT07092319, which also lists 9 linked publications.

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 29 Jul 2025.

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