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Cut umbilical cord milking (C-UCM) as a mode of placental transfusion in non-vigorous preterm neonates: a randomized controlled trial

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Abstract

Routine practice of delayed cord clamping (DCC) is the standard of care in vigorous neonates. However there is no consensus on the recommended approach to placental transfusion in non-vigorous neonates. In this trial, we tried to examine the effect of cut umbilical cord milking (C-UCM) as compared to early cord clamping (ECC) on hematological and clinical hemodynamic parameters in non-vigorous preterm neonates of 30–35 weeks gestation. The primary outcome assessed was venous hematocrit (Hct) at 48 (± 4) hours of postnatal age. The important secondary outcomes assessed were serum ferritin at 6 weeks of age, mean blood pressure in the initial transitional phase along with important neonatal morbidities and potential complications. In this single centre randomized controlled trial, 134 non vigorous neonates of 30–35 weeks gestation were allocated in a 1:1 ratio to either C-UCM (n = 67) or ECC (n = 67). For statistical analysis, unpaired Student t and Chi square or Fisher’s exact test were used. The mean Hct at 48 h was higher in the C-UCM group as compared to the control group, 50.24(4.200) vs 46.16(2.957), p < .0001. Also significantly higher was the mean Hct at 12 h, 6 weeks and mean serum ferritin at 6 weeks of age in the milked group (p < .0001). Mean blood pressure at 1 h and 6 h was also significantly higher in the milked arm. Need for transfusion and inotropes was less in the milked group but not statistically significant. No significant difference in potential complications was observed between the groups.

   Conclusion: C-UCM stabilizes initial blood pressure and results in higher hematocrit and improved iron stores. It can be an alternative to DCC in non-vigorous preterm neonates of 30–35 weeks’ gestation. Further large multicentric studies are needed to fully establish its efficacy and safety.

   Trial registration: CTRI/2021/12/038606; registration date December 14, 2021.

What is Known:

• DCC is the routinely recommended method of placental transfusion for vigorous neonates but no consensus exist for neonates requiring resuscitation at birth.

• C-UCM is easier to perform in non-vigorous neonates but there is paucity of studies in the preterm population.

What is New:

• C-UCM is effective as well as safe in non-vigorous preterm neonates of 30–35 weeks gestational age.

• C-UCM holds promise as an alternative to DCC, especially in resource limited settings and in situations where the later is not feasible.

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Data Availability

Available for viewing at https://docs.google.com/spreadsheets/d/17wFHTXUXTu-lhU1YNxSvfwDptsyzbw7n/edit?usp=sharing&ouid=110669444824295618958&rtpof=true&sd=true.

Abbreviations

C-UCM:

Cut umbilical cord milking

DCC:

Delayed cord clamping

ECC:

Early/immediate cord clamping

Hb:

Hemoglobin

Hct:

Hematocrit

ILCOR:

International Liaison Committee on Resuscitation

I-UCM:

Intact umbilical cord milking

IVH:

Intraventricular hemorrhage

MINVI:

Milking in non-vigorous infants

NRP:

Neonatal resuscitation program

PRBC:

Packed red blood cell

SD:

Standard deviation

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Acknowledgements

We thank the babies and their parents, nurses and residents of the unit. We offer our sincere gratitude to the laboratory technicians for their help and support.

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Authors and Affiliations

Authors

Contributions

The study was conceptualized, designed and first protocol was developed by Rajib Losan Bora. Bijan Saha and Sambhunath Bandyopadhyay contributed significantly in each stage and improved the content. Bijan Saha and Suchandra Mukherjee reviewed and finalised the protocol. Rajib Losan Bora did the data collection supervised by Bijan Saha and Sambhunath Bandyopadhyay. Abhijit Hazra did the data analysis. Rajib Losan Bora prepared the first draft. Suchandra Mukherjee and Sambhunath Bandyopadhyay critically reviewed the manuscript. Rajib Losan Bora and Bijan Saha revised and finalised the manuscript. All the authors approved the final manuscript as submitted and agree to be accountable for all aspect of the work.

Corresponding author

Correspondence to Bijan Saha.

Ethics declarations

Ethics approval

The study was conducted in conformity with the Declaration of Helsinki's ethical standards and in a manner that was consistent with good clinical practice. Approval of the trial was obtained from institutional ethics committee of the Institute of Post Graduate Medical Education and Research, Kolkata, India (IPGME&R/IEC/2021/490). The study's registration number with the Clinical Trial Registry of India (CTRI) was CTRI/2021/12/038606.

Consent to participate

Informed written consent was obtained from all legal guardians before participating in the study.

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Informed written consent was obtained from parents or authorized legal guardian of all included participants for publication of anonymous patients’ data.

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The authors declare no potential conflict of interest.

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Communicated by Daniele De Luca

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Bora, R.L., Bandyopadhyay, S., Saha, B. et al. Cut umbilical cord milking (C-UCM) as a mode of placental transfusion in non-vigorous preterm neonates: a randomized controlled trial. Eur J Pediatr 182, 3883–3891 (2023). https://doi.org/10.1007/s00431-023-05063-4

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  • DOI: https://doi.org/10.1007/s00431-023-05063-4

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