Umbilical Cord Milking Versus Delayed Cord Clamping in Infants 28 to 32 Weeks: A Randomized Trial

Anup Katheria; Jeff Szychowski; Waldemar A. Carlo; Akila Subramaniam; Frank Reister; Jochen Essers; Farha Vora; Courtney Martin; Georg M. Schmeolzer; Brenda Law; Eugene Dempsey; Keelin O’Donoghue; Joseph Kaempf; Mark Tomlinson; Kevin Fulford; Bergen Folsom; Simon Karam; Rachael Morris; Toby Yanowitz; Stacy Beck; Erin Clark; Tara DuPont; Manoj Biniwale; Rangasamy Ramanathan; Shazia Bhat; Matthew Hoffman; Nitin Chouthai; Fayez Bany-Mohammed; Janardhan Mydam; Vivek Narendran; Fiona Wertheimer; Yvonne Gollin; Yvonne Vaucher; Kathy Arnell; Michael Varner; Gary Cutter; Nicole Wilson; Wade Rich; Neil Finer

doi:10.1542/peds.2023-063113

Umbilical Cord Milking Versus Delayed Cord Clamping in Infants 28 to 32 Weeks: A Randomized Trial

Anup Katheria, Jeff Szychowski, Waldemar A. Carlo, Akila Subramaniam, Frank Reister, Jochen Essers, Farha Vora, Courtney Martin, Georg M. Schmeolzer, Brenda Law, Eugene Dempsey, Keelin O’Donoghue, Joseph Kaempf, Mark Tomlinson, Kevin Fulford, Bergen Folsom, Simon Karam, Rachael Morris, Toby Yanowitz, Stacy BeckErin Clark, Tara DuPont, Manoj Biniwale, Rangasamy Ramanathan, Shazia Bhat, Matthew Hoffman, Nitin Chouthai, Fayez Bany-Mohammed, Janardhan Mydam, Vivek Narendran, Fiona Wertheimer, Yvonne Gollin, Yvonne Vaucher, Kathy Arnell, Michael Varner, Gary Cutter, Nicole Wilson, Wade Rich, Neil Finer

Research output: Contribution to journal › Article › peer-review

2 Scopus citations

Abstract

OBJECTIVES: To determine whether rate of severe intraventricular hemorrhage (IVH) or death among preterm infants receiving placental transfusion with UCM is noninferior to delayed cord clamping (DCC). METHODS: Noninferiority randomized controlled trial comparing UCM versus DCC in preterm infants born 28 to 32 weeks recruited between June 2017 through September 2022 from 19 university and private medical centers in 4 countries. The primary outcome was Grade III/IV IVH or death evaluated at a 1% noninferiority margin. RESULTS: Among 1019 infants (UCM n 5 511 and DCC n 5 508), all completed the trial from birth through initial hospitalization (mean gestational age 31 weeks, 44% female). For the primary outcome, 7 of 511 (1.4%) infants randomized to UCM developed severe IVH or died compared to 7 of 508 (1.4%) infants randomized to DCC (rate difference 0.01%, 95% confidence interval: (1.4% to 1.4%), P 5 .99). CONCLUSIONS: In this randomized controlled trial of UCM versus DCC among preterm infants born between 28 and 32 weeks’ gestation, there was no difference in the rates of severe IVH or death. UCM may be a safe alternative to DCC in premature infants born at 28 to 32 weeks who require resuscitation.

Original language	English (US)
Article number	e20230631
Journal	Pediatrics
Volume	152
Issue number	6
DOIs	https://doi.org/10.1542/peds.2023-063113
State	Published - Dec 1 2023
Externally published	Yes

ASJC Scopus subject areas

Pediatrics, Perinatology, and Child Health

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10.1542/peds.2023-063113

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Katheria, A., Szychowski, J., Carlo, W. A., Subramaniam, A., Reister, F., Essers, J., Vora, F., Martin, C., Schmeolzer, G. M., Law, B., Dempsey, E., O’Donoghue, K., Kaempf, J., Tomlinson, M., Fulford, K., Folsom, B., Karam, S., Morris, R., Yanowitz, T., ... Finer, N. (2023). Umbilical Cord Milking Versus Delayed Cord Clamping in Infants 28 to 32 Weeks: A Randomized Trial. Pediatrics, 152(6), Article e20230631. https://doi.org/10.1542/peds.2023-063113

Katheria, A, Szychowski, J, Carlo, WA, Subramaniam, A, Reister, F, Essers, J, Vora, F, Martin, C, Schmeolzer, GM, Law, B, Dempsey, E, O’Donoghue, K, Kaempf, J, Tomlinson, M, Fulford, K, Folsom, B, Karam, S, Morris, R, Yanowitz, T, Beck, S, Clark, E, DuPont, T, Biniwale, M, Ramanathan, R, Bhat, S, Hoffman, M, Chouthai, N, Bany-Mohammed, F, Mydam, J, Narendran, V, Wertheimer, F, Gollin, Y, Vaucher, Y, Arnell, K, Varner, M, Cutter, G, Wilson, N, Rich, W & Finer, N 2023, 'Umbilical Cord Milking Versus Delayed Cord Clamping in Infants 28 to 32 Weeks: A Randomized Trial', Pediatrics, vol. 152, no. 6, e20230631. https://doi.org/10.1542/peds.2023-063113

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title = "Umbilical Cord Milking Versus Delayed Cord Clamping in Infants 28 to 32 Weeks: A Randomized Trial",

abstract = "OBJECTIVES: To determine whether rate of severe intraventricular hemorrhage (IVH) or death among preterm infants receiving placental transfusion with UCM is noninferior to delayed cord clamping (DCC). METHODS: Noninferiority randomized controlled trial comparing UCM versus DCC in preterm infants born 28 to 32 weeks recruited between June 2017 through September 2022 from 19 university and private medical centers in 4 countries. The primary outcome was Grade III/IV IVH or death evaluated at a 1% noninferiority margin. RESULTS: Among 1019 infants (UCM n 5 511 and DCC n 5 508), all completed the trial from birth through initial hospitalization (mean gestational age 31 weeks, 44% female). For the primary outcome, 7 of 511 (1.4%) infants randomized to UCM developed severe IVH or died compared to 7 of 508 (1.4%) infants randomized to DCC (rate difference 0.01%, 95% confidence interval: (1.4% to 1.4%), P 5 .99). CONCLUSIONS: In this randomized controlled trial of UCM versus DCC among preterm infants born between 28 and 32 weeks{\textquoteright} gestation, there was no difference in the rates of severe IVH or death. UCM may be a safe alternative to DCC in premature infants born at 28 to 32 weeks who require resuscitation.",

author = "Anup Katheria and Jeff Szychowski and Carlo, {Waldemar A.} and Akila Subramaniam and Frank Reister and Jochen Essers and Farha Vora and Courtney Martin and Schmeolzer, {Georg M.} and Brenda Law and Eugene Dempsey and Keelin O{\textquoteright}Donoghue and Joseph Kaempf and Mark Tomlinson and Kevin Fulford and Bergen Folsom and Simon Karam and Rachael Morris and Toby Yanowitz and Stacy Beck and Erin Clark and Tara DuPont and Manoj Biniwale and Rangasamy Ramanathan and Shazia Bhat and Matthew Hoffman and Nitin Chouthai and Fayez Bany-Mohammed and Janardhan Mydam and Vivek Narendran and Fiona Wertheimer and Yvonne Gollin and Yvonne Vaucher and Kathy Arnell and Michael Varner and Gary Cutter and Nicole Wilson and Wade Rich and Neil Finer",

note = "Publisher Copyright: Copyright {\textcopyright} 2023 by the American Academy of Pediatrics.",

year = "2023",

month = dec,

day = "1",

doi = "10.1542/peds.2023-063113",

language = "English (US)",

volume = "152",

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TY - JOUR

T1 - Umbilical Cord Milking Versus Delayed Cord Clamping in Infants 28 to 32 Weeks

T2 - A Randomized Trial

AU - Katheria, Anup

AU - Szychowski, Jeff

AU - Carlo, Waldemar A.

AU - Subramaniam, Akila

AU - Reister, Frank

AU - Essers, Jochen

AU - Vora, Farha

AU - Martin, Courtney

AU - Schmeolzer, Georg M.

AU - Law, Brenda

AU - Dempsey, Eugene

AU - O’Donoghue, Keelin

AU - Kaempf, Joseph

AU - Tomlinson, Mark

AU - Fulford, Kevin

AU - Folsom, Bergen

AU - Karam, Simon

AU - Morris, Rachael

AU - Yanowitz, Toby

AU - Beck, Stacy

AU - Clark, Erin

AU - DuPont, Tara

AU - Biniwale, Manoj

AU - Ramanathan, Rangasamy

AU - Bhat, Shazia

AU - Hoffman, Matthew

AU - Chouthai, Nitin

AU - Bany-Mohammed, Fayez

AU - Mydam, Janardhan

AU - Narendran, Vivek

AU - Wertheimer, Fiona

AU - Gollin, Yvonne

AU - Vaucher, Yvonne

AU - Arnell, Kathy

AU - Varner, Michael

AU - Cutter, Gary

AU - Wilson, Nicole

AU - Rich, Wade

AU - Finer, Neil

PY - 2023/12/1

Y1 - 2023/12/1

N2 - OBJECTIVES: To determine whether rate of severe intraventricular hemorrhage (IVH) or death among preterm infants receiving placental transfusion with UCM is noninferior to delayed cord clamping (DCC). METHODS: Noninferiority randomized controlled trial comparing UCM versus DCC in preterm infants born 28 to 32 weeks recruited between June 2017 through September 2022 from 19 university and private medical centers in 4 countries. The primary outcome was Grade III/IV IVH or death evaluated at a 1% noninferiority margin. RESULTS: Among 1019 infants (UCM n 5 511 and DCC n 5 508), all completed the trial from birth through initial hospitalization (mean gestational age 31 weeks, 44% female). For the primary outcome, 7 of 511 (1.4%) infants randomized to UCM developed severe IVH or died compared to 7 of 508 (1.4%) infants randomized to DCC (rate difference 0.01%, 95% confidence interval: (1.4% to 1.4%), P 5 .99). CONCLUSIONS: In this randomized controlled trial of UCM versus DCC among preterm infants born between 28 and 32 weeks’ gestation, there was no difference in the rates of severe IVH or death. UCM may be a safe alternative to DCC in premature infants born at 28 to 32 weeks who require resuscitation.

AB - OBJECTIVES: To determine whether rate of severe intraventricular hemorrhage (IVH) or death among preterm infants receiving placental transfusion with UCM is noninferior to delayed cord clamping (DCC). METHODS: Noninferiority randomized controlled trial comparing UCM versus DCC in preterm infants born 28 to 32 weeks recruited between June 2017 through September 2022 from 19 university and private medical centers in 4 countries. The primary outcome was Grade III/IV IVH or death evaluated at a 1% noninferiority margin. RESULTS: Among 1019 infants (UCM n 5 511 and DCC n 5 508), all completed the trial from birth through initial hospitalization (mean gestational age 31 weeks, 44% female). For the primary outcome, 7 of 511 (1.4%) infants randomized to UCM developed severe IVH or died compared to 7 of 508 (1.4%) infants randomized to DCC (rate difference 0.01%, 95% confidence interval: (1.4% to 1.4%), P 5 .99). CONCLUSIONS: In this randomized controlled trial of UCM versus DCC among preterm infants born between 28 and 32 weeks’ gestation, there was no difference in the rates of severe IVH or death. UCM may be a safe alternative to DCC in premature infants born at 28 to 32 weeks who require resuscitation.

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Umbilical Cord Milking Versus Delayed Cord Clamping in Infants 28 to 32 Weeks: A Randomized Trial

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