Download PDF
Am J Perinatol 2019; 36(14): 1492-1497
DOI: 10.1055/s-0039-1678530
Original Article
Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

A Multicentered Randomized Study on Early versus Rescue Calsurf Administration for the Treatment of Respiratory Distress Syndrome in Preterm Infants

Zhihui Rong
1   Neonatal Intensive Care Unit, Tongji Hospital, Huazhong University of Science and Technology, Wuhan, Hubei, China
,
Liwen Chang
1   Neonatal Intensive Care Unit, Tongji Hospital, Huazhong University of Science and Technology, Wuhan, Hubei, China
,
Hongbin Cheng
2   Neonatal Intensive Care Unit, Huangshi Maternity and Children's Healthy Hospital, Huangshi, Hubei, China
,
Huizhen Wang
3   Neonatal Intensive Care Unit, Wuhan Children’s Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
,
Xiaofang Zhu
4   Neonatal Intensive Care Unit, Jingzhou Central Hospital, Jingzhou, Hubei, China
,
Fen Peng
5   Neonatal Intensive Care Unit, University Hospital of Hubei University for Nationalities, Wuhan, Hubei, China
,
Qihong Fan
6   Neonatal Intensive Care Unit, The First Affiliated Hospital of Yangtze University, The First People's Hospital of Jingzhou, Jingzhou, Hubei, China
,
Wei Lu
7   Neonatal Intensive Care Unit, The First Clinical Medical School of the Three Gorges University Yichang Central People's Hospital, Yichang, Hubei, China
,
Rui Pan
8   Neonatal Intensive Care Unit, Xiangyang Central Hospital, Xiangyang, Hubei, China
,
Li Xiong
9   Neonatal Intensive Care Unit, The First People's Hospital of Tianmen, Tianmen, Hubei, China
,
Rong Jiao
10   Neonatal Intensive Care Unit, Hubei University of Medicine, Xiangyang No. 1 People's Hospital, Xiangyang, Hubei, China
,
Jie Sun
11   Neonatal Intensive Care Unit, Huanggang Central Hospital, Huanggang, Hubei, China
,
Shiwen Xia
12   Neonatal Intensive Care Unit, Hubei Maternal and Child Health Hospital, Wuhan, Hubei, China
,
Jijian Xie
13   Neonatal Intensive Care Unit, Taihe Hospital, Shiyan, Hubei, China
› Author Affiliations Funding This study was supported by the research clinicians of Huazhong University of Science and Technology (second batch) and China International Medical Foundation 2018.
Further Information

Publication History

30 August 2018

03 January 2019

Publication Date:
04 February 2019 (online)

Also available at
    Permissions and Reprints

Abstract

Objective Surfactant and noninvasive ventilation are two major strategies for the treatment of neonates with respiratory distress syndrome (RDS). However, the optimal time for surfactant administering is yet controversial. This study compared the early and rescue Calsurf administration in preterm infants with RDS.

Study Design Preterm infants born between 260/7 and 326/7 weeks of gestation and needed nasal continuous positive airway pressure (nCPAP) immediately after birth were randomly assigned to the early or rescue Calsurf treatment group. In the early treatment group, neonates were intubated, administered surfactant with bag–mask ventilation, and extubated to nCPAP (INSURE [intubation–surfactant–extubation]). In the rescue treatment group, InSurE was given until the clinical manifestation and chest X-ray displayed RDS. The primary outcome was to compare the reintubation rate within 72 hour age between the two groups.

Results Among 305 neonates randomized to the early (n = 154) and rescue (n = 151) groups, the reintubation rate within 72 hours of age in these two groups did not differ significantly (p > 0.05). The incidence of oxygen dependence until 36 weeks' corrected age was similar in both groups.

Conclusion No differences were observed between early and rescue Calsurf treatment groups with respect to the reintubation rate within 72 hours of age and the incidence of bronchopulmonary dysplasia.

Keywords

continuous positive airway pressure - neonatal respiratory distress syndrome - bronchopulmonary dysplasia - surfactant

Note

All the authors contributed equally to the study.


 

  • References

  • 1 Rojas MA, Lozano JM, Rojas MX. , et al; Colombian Neonatal Research Network. Very early surfactant without mandatory ventilation in premature infants treated with early continuous positive airway pressure: a randomized, controlled trial. Pediatrics 2009; 123 (01) 137-142
    CrossrefPubMedSearch in Google Scholar
  • 2 Dargaville PA, Aiyappan A, De Paoli AG. , et al. Continuous positive airway pressure failure in preterm infants: incidence, predictors and consequences. Neonatology 2013; 104 (01) 8-14
    CrossrefPubMedSearch in Google Scholar
  • 3 Chang LW. Collaborative Study Group for Bronchopulmonary Dysplasia of Prematurity in China. Incidence and risk factors of bronchopulmonary dysplasia in prematureinfants in 10 hospitals in China [in Chinese]. Zhonghua Er Ke Za Zhi 2011; 49 (09) 655-662
    PubMedSearch in Google Scholar
  • 4 Rong ZH, Li WB, Liu W. , et al. Nasal bi-level positive airway pressure (BiPAP) versus nasal continuous positive airway pressure (CPAP) in preterm infants ≤32 weeks: a retrospective cohort study. J Paediatr Child Health 2016; 52: 493-498
    CrossrefPubMedSearch in Google Scholar
  • 5 Eibisberger M, Resch E, Resch B. Surfactant replacement therapy in extremely low gestational age newborns. Indian Pediatr 2015; 52 (03) 227-230
    CrossrefPubMedSearch in Google Scholar
  • 6 Iyer NP, Mhanna MJ. The role of surfactant and non-invasive mechanical ventilation in early management of respiratory distress syndrome in premature infants. World J Pediatr 2014; 10 (03) 204-210
    CrossrefPubMedSearch in Google Scholar
  • 7 Seger N, Soll R. Animal derived surfactant extract for treatment of respiratory distress syndrome. Cochrane Database Syst Rev 2009; (02) CD007836
    PubMedSearch in Google Scholar
  • 8 Engle WA. ; American Academy of Pediatrics Committee on Fetus and Newborn. Surfactant-replacement therapy for respiratory distress in the preterm and term neonate. Pediatrics 2008; 121 (02) 419-432
    CrossrefPubMedSearch in Google Scholar
  • 9 Morley CJ, Davis PG, Doyle LW, Brion LP, Hascoet JM, Carlin JB. ; COIN Trial Investigators. Nasal CPAP or intubation at birth for very preterm infants. N Engl J Med 2008; 358 (07) 700-708
    CrossrefPubMedSearch in Google Scholar
  • 10 Rojas-Reyes MX, Morley CJ, Soll R. Prophylactic versus selective use of surfactant in preventing morbidity and mortality in preterm infants. Cochrane Database Syst Rev 2012; (03) CD000510
    PubMedSearch in Google Scholar
  • 11 Committee on Fetus and Newborn; American Academy of Pediatrics. Respiratory support in preterm infants at birth. Pediatrics 2014; 133 (01) 171-174
    CrossrefPubMedSearch in Google Scholar
  • 12 Kong X, Cui Q, Hu Y. , et al. Bovine surfactant replacement therapy in neonates of less than 32 weeks' gestation: a multicenter controlled trial of prophylaxis versus early treatment in China--a pilot study. Pediatr Neonatol 2016; 57 (01) 19-26
    CrossrefPubMedSearch in Google Scholar
  • 13 Liu J, Yang N, Liu Y. High-risk factors of respiratory distress syndrome in term neonates: a retrospective case-control study. Balkan Med J 2014; 31 (01) 64-68
    PubMedSearch in Google Scholar
  • 14 Isayama T, Chai-Adisaksopha C, McDonald SD. Noninvasive ventilation with vs without early surfactant to prevent chronic lung disease in preterm infants: a systematic review and meta-analysis. JAMA Pediatr 2015; 169 (08) 731-739
    CrossrefPubMedSearch in Google Scholar
  • 15 Stevens TP, Harrington EW, Blennow M, Soll RF. Early surfactant administration with brief ventilation vs. selective surfactant and continued mechanical ventilation for preterm infants with or at risk for respiratory distress syndrome. Cochrane Database Syst Rev 2007; (04) CD003063
    PubMedSearch in Google Scholar
  • 16 Sandri F, Plavka R, Ancora G. , et al; CURPAP Study Group. Prophylactic or early selective surfactant combined with nCPAP in very preterm infants. Pediatrics 2010; 125 (06) e1402-e1409
    CrossrefPubMedSearch in Google Scholar
  • 17 Dunn MS, Kaempf J, de Klerk A. , et al; Vermont Oxford Network DRM Study Group. Randomized trial comparing 3 approaches to the initial respiratory management of preterm neonates. Pediatrics 2011; 128 (05) e1069-e1076
    CrossrefPubMedSearch in Google Scholar
  • 18 Kandraju H, Murki S, Subramanian S, Gaddam P, Deorari A, Kumar P. Early routine versus late selective surfactant in preterm neonates with respiratory distress syndrome on nasal continuous positive airway pressure: a randomized controlled trial. Neonatology 2013; 103 (02) 148-154
    CrossrefPubMedSearch in Google Scholar