Timing of Umbilical Cord Clamping in Preterm Neonates

NCT06000800 | Completed

• 1 other identifier: Cord Clamping
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

Umbilical cord clamping is an important intervention that routinely done for all neonates afterbirth. yet the optimal timing for this intervention remains controversial

Conditions

Cord Clamping

Keywords

Umbilical cord clamping; Preterm Neonates; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (7)

• neonatal APGAR score

  quick test performed at 1 and 5 minutes after birth to determine the physical condition of the newborn. The five categories assessed are heart rate, respiratory effort, muscle tone, reflex irritability, and color ( score from 8-10 means normal) score from 7-4 moderate asphyxia, from 1-3 sever asphyxia

  1st, 5th and 10th minutes of life

• neonatal vital signs

  respiration

  1st,6th,12th, 24th, and 48th hours

• neonatal vital signs

  pulse

  1st,6th,12th, 24th, and 48th hours

• neonatal vital signs

  temperature

  1st,6th,12th, 24th, and 48th hours

• neonatal hemoglobin

  measuring this labs for neonate

  1st,6th,12th, 24th, and 48th hours

• neonatal hematocrit

  measuring this labs for neonate

  1st,6th,12th, 24th, and 48th hours

• neonatal bilirubin level test

  measuring this labs for neonate

  1st,6th,12th, 24th, and 48th hours

Secondary Outcomes (2)

• blood glucose

  1st,6th,12th, 24th, and 48th hours

• oxygen saturation

  1st,6th,12th, 24th, and 48th hours

Study Arms (4)

Group (clamping at 30 seconds)

EXPERIMENTAL

Umbilical cord clamping at 30 seconds

Other: Group B

Group clamping at 60 seconds

EXPERIMENTAL

Umbilical cord clamping at 60 seconds

Other: Group C

Group clamping at 90 seconds

EXPERIMENTAL

Umbilical cord clamping at 90 seconds

Other: Group D

Group clamping immediately

ACTIVE COMPARATOR

Umbilical cord clamping immediately after birth (5 second)

Other: Group A

Interventions

Group B OTHER

Umbilical cord clamping at 30 seconds

Group (clamping at 30 seconds)

Group C OTHER

Umbilical cord clamping at 60 seconds

Group clamping at 60 seconds

Group D OTHER

Umbilical cord clamping at 90 seconds

Group clamping at 90 seconds

Group A OTHER

Umbilical cord clamping immediately after birth (5 second)

Group clamping immediately

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy pregnant mothers
• singleton fetuses
• preterm cesarian delivery

You may not qualify if:

• asphyxiated neonates
• twins
• mothers with any medical or obstetrical conditions occurring intrapartum such as hemorrhage, or eclampsia.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of nursinf

Cairo, 12519, Egypt

Location

Related Publications (7)

• Alzaree F, Elbohoty A, Abdellatif M. Early Versus Delayed Umbilical Cord Clamping on Physiologic Anemia of the Term Newborn Infant. Open Access Maced J Med Sci. 2018 Aug 15;6(8):1399-1404. doi: 10.3889/oamjms.2018.286. eCollection 2018 Aug 20.

  PMID: 30159064 BACKGROUND

• American College of Obstetricians and Gynecologists' Committee on Obstetric Practice. Delayed Umbilical Cord Clamping After Birth: ACOG Committee Opinion, Number 814. Obstet Gynecol. 2020 Dec;136(6):e100-e106. doi: 10.1097/AOG.0000000000004167.

  PMID: 33214530 BACKGROUND

• Kc A, Rana N, Malqvist M, Jarawka Ranneberg L, Subedi K, Andersson O. Effects of Delayed Umbilical Cord Clamping vs Early Clamping on Anemia in Infants at 8 and 12 Months: A Randomized Clinical Trial. JAMA Pediatr. 2017 Mar 1;171(3):264-270. doi: 10.1001/jamapediatrics.2016.3971.

  PMID: 28114607 BACKGROUND

• Bianchi A, Jacobsson B, Mol BW; FIGO Working Group for Preterm Birth. FIGO good practice recommendations on delayed umbilical cord clamping. Int J Gynaecol Obstet. 2021 Oct;155(1):34-36. doi: 10.1002/ijgo.13841.

  PMID: 34520061 BACKGROUND

• Brown BE, Shah PS, Afifi JK, Sherlock RL, Adie MA, Monterrosa LA, Crane JM, Ye XY, El-Naggar WI; Canadian Neonatal Network; Canadian Preterm Birth Network Investigators. Delayed cord clamping in small for gestational age preterm infants. Am J Obstet Gynecol. 2022 Feb;226(2):247.e1-247.e10. doi: 10.1016/j.ajog.2021.08.003. Epub 2021 Aug 9.

  PMID: 34384773 BACKGROUND

• Chiruvolu A, Mallett LH, Govande VP, Raju VN, Hammonds K, Katheria AC. Variations in umbilical cord clamping practices in the United States: a national survey of neonatologists. J Matern Fetal Neonatal Med. 2022 Oct;35(19):3646-3652. doi: 10.1080/14767058.2020.1836150. Epub 2020 Oct 20.

  PMID: 33081557 BACKGROUND

• Deindl P, Diemert A. From structural modalities in perinatal medicine to the frequency of preterm birth. Semin Immunopathol. 2020 Aug;42(4):377-383. doi: 10.1007/s00281-020-00805-0. Epub 2020 Aug 25.

  PMID: 32840641 BACKGROUND

Study Officials

• Lawahez M. Dwedar, lecturer

  faculty of nursing

  STUDY CHAIR

• Fatma Atta, lecturer

  faculty of medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The trial was unblinded; where the participants and researchers were aware of the group a participant belonged to
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of maternal and newborn health nursing

Model Details: A randomized controlled trial was used to fulfill the aim of the study. The randomized control trial (RCT) is a trial in which subjects are randomly assigned to one of two groups: one (the experimental group) receiving the intervention that is being tested, and the other (the comparison group or control group) receiving an alternative treatment

Study Record Dates

• First Submitted: August 8, 2023
• First Posted: August 21, 2023
• Study Start: November 18, 2021
• Primary Completion: November 21, 2022
• Study Completion: December 21, 2022
• Last Updated: August 21, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 2 months
• Access Criteria: will be published on magazine

Locations

EG (1)