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

NCT07092319 | Not Yet Recruiting DMC

• 1 other identifier: M2024376
• Study Type: observational
• Target: 518
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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.

Conditions

NRDS

Keywords

Delayed cord clamping; minimally invasive surfactant administration; preterm infants

Outcome Measures

Primary Outcomes (1)

• incidence of bronchopulmonary dysplasia

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

  At 36 weeks PMA

Secondary Outcomes (10)

• Rate of patent ductus arteriosus with hemodynamic changes

  From enrollment to 30 days after birth

• Rate of air leakage, pulmonary hemorrhage, infectious pneumonia

  Through study completion and up to corrected three months

• Rate of late onset sepsis with positive blood culture

  Through study completion and up to corrected three months

• Rate of retinopathy of prematurity

  Through study completion and up to corrected three months

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

  Through study completion and up to corrected three months

Study Arms (3)

DCC+MISA group

Infants 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.

Procedure: deferred cord clamping

ICC+tracheal intubation group

Umbilical 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 group

Umbilical 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.

Interventions

deferred cord clamping PROCEDURE

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

Also known as: minimally invasive surfactant administration

DCC+MISA group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, China

Location

Related Publications (9)

• 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.

  PMID: 29097178 BACKGROUND

• 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.

  PMID: 37436461 BACKGROUND

• 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.

  PMID: 37833351 BACKGROUND

• 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.

  PMID: 37349189 BACKGROUND

• 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.

  PMID: 35300830 BACKGROUND

• 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.

  PMID: 27603539 BACKGROUND

• 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.

  PMID: 28745986 BACKGROUND

• 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.

  PMID: 31587861 BACKGROUND

• 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.

  PMID: 41341102 DERIVED

Central Study Contacts

Tongyan Han

CONTACT

+8615611963386; tongyanhan@bjmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: July 29, 2025
• Study Start: August 30, 2025
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CN (1)