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A randomised controlled trial comparing umbilical cord milking to delayed cord clamping at birth in preterm infants 28–36 weeks gestational age

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Abstract

Delayed cord clamping (DCC) is an established practice in perinatology with multiple benefits. However, in instances where the implementation of DCC is not viable, it needs alternatives, especially during caesarean deliveries. A non-inferiority randomized, non-blinded, trial was conducted at a tertiary care referral unit in South India among the preterm newborns (28–36 weeks) randomized to DCC as opposed to intact-umbilical cord milking (UCM). The primary objective was to compare the mean haemoglobin values between the two groups, and the secondary outcome was to compare death and/or major IVH (> Grade II). Of the 132 eligible newborn infants, 99 were randomized to two study groups. Of the 59 and 40 randomised to UCM and DCC, 54 and 36 received the allocated intervention respectively. Preterm infants who underwent UCM had significantly higher haemoglobin (19.97 ± 1.44) as compared to DCC group (18.62 ± 0.98) p-0.0001. The rates of mortality and/or major IVH were comparable between the two groups.

Conclusion: UCM may be a feasible alternative to DCC especially in settings where the latter is not achievable, without increasing the risk of adverse effects to the preterm infants, this finding needing further confirmation with larger sample.

Trial registration: CTRI (Clinical Trial Registry—India) registration number: CTRI/2020/04/024566 (registered prospectively on 13/04/2020).

What is Known:

• Delayed cord clamping (DCC) is recommended as a standard of care for all the stable term and preterm newborn babies at birth.

What is New:

• Intact umbilical cord milking may be a reasonable choice of cord management when DCC is unsuccessful, without increasing adverse effects for the new born.

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Data availability

The data that support the findings of this study are available from the corresponding author, upon reasonable request.

Abbreviations

AHA:

American Heart Association

CD:

Caesarean delivery

DCC:

Delayed cord clamping

ECC:

Early cord clamping

ICC:

Immediate cord clamping

UCM:

Intact-umbilical cord milking

IVH:

Intraventricular haemorrhage

NEC:

Necrotising enterocolitis

VD:

Vaginal delivery

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Acknowledgements

Dr R M Desai, Dr Asha Neravi, Dr Vidya Kamath , Dr Sunitha T H - the obstetric team and Dr. Vijay Kulkarni, Dr. Praveen Bagalkot, Dr. Kavita Konded and all the pediatricians of SDM CMS &H for helping with the mother-new born care.

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Authors and Affiliations

  1. SDM College of Medical Sciences and Hospital, Dharwad, Karnataka, India

    Nitin Narayan Rao

  2. Department of Paediatrics, SDM College of Medical Sciences and Hospital, Dharwad, Karnataka, India

    Kulkarni Poornima Prakash

  3. Department of Paediatrics and Neonatology, SDM College of Medical Sciences and Hospital, Dharwad, Karnataka, India

    Anita Nyamagoudar

Authors
  1. Nitin Narayan Rao
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  2. Kulkarni Poornima Prakash
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  3. Anita Nyamagoudar
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Contributions

Kulkarni Poornima Prakash conceived the study; Nitin Narayan Rao acquired the data. Kulkarni Poornima Prakash, Anita Nyamagoudar and Nitin Narayan Rao analysed and interpreted the data. Nitin Narayan Rao drafted the manuscript. Anita Nyamagoudar and Kulkarni Poornima Prakash revised the work with intellectual content. All the three authors agree to be accountable for all the aspects of the work.

Corresponding author

Correspondence to Anita Nyamagoudar.

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Ethics approval

Ethical approval has been obtained from the Institutional Ethics Committee. The copy of the same has been attached below. The Ethics Committee monitors and approves the research as per Schedule Y and CDSCO (Central Drugs Standard Control Organization) guidelines (Rule 7 of the New drugs and Clinical Trial Rules, 2019), ICH GCP guidelines, and ethical guidelines for Biomedical and Health Research involving Human Participants, Indian Council of Medical Research (ICMR), and Department of Health Research (DHR).

Competing interests

The authors declare no competing of interests.

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Communicated by Daniele De Luca

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Rao, N.N., Prakash, K.P. & Nyamagoudar, A. A randomised controlled trial comparing umbilical cord milking to delayed cord clamping at birth in preterm infants 28–36 weeks gestational age. Eur J Pediatr (2024). https://doi.org/10.1007/s00431-024-05550-2

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  • DOI: https://doi.org/10.1007/s00431-024-05550-2

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