Recruiting

Observational Study

Sponsor:

IWK Health Centre

Code:

NCT03852134

Conditions

Preterm Infant

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

MOCC Group

DCC Group

Study Details

Brief summary:

In this feasibility study, the investigators will randomize preterm infants born at <32 weeks gestation to either the standard practice of delayed cord clamping (DCC) for 30-60 seconds at birth or milking of the long-cut cord (MOCC) while providing resuscitation/stabilization to the infant. The main objectives of the trial are to assess the feasibility of the new approach (MOCC) and to compare the two groups regarding the hemoglobin levels on admission to NICU in addition to neonatal morbidity and mortality.

Conditions

Preterm Infant

Study ID

NCT03852134

Start date

Feb 7, 2019

Status verified date

Feb, 2019

Completion date

Jul 31, 2023

Anticipated

Primary completion date

Feb 7, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Preterm infants <32 weeks' gestation

Exclusion Criteria:

  • Clinical evidence of interrupted placental circulation (placental abruption or avulsed cord) or bleeding from placenta previa.
  • Monochorionic twins or any higher order multiple pregnancy
  • Major fetal congenital or chromosomal abnormality
  • Documented fetal anemia or in utero red blood cell transfusion
  • Intent to withhold or withdraw treatment of the infant

Study Design

Enrollment

98 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: MOCC Group

The OB provider will hold the baby at/below the placenta, provide warmth, stimulate the baby and suction the mouth/nose for 30 secs.S/He will then clamp and cut the cord about 5 cm from the the introitus (vaginal deliveries) or from the abdominal incision (C-Sections) before handing the baby with the long-cut cord to the neonatal team to resuscitate/ stabilize the baby. A member of the neonatal team will milk the long-cut cord slowly 1 time from the cut end toward the infant over 10 secs before clamping and cutting the cord 1-2 cm from the umbilical stump. The neonatal team will provide PPV to the baby (during the milking process) if the baby is not breathing. If the baby is breathing during the milking process the team will continue the stabilization as per standard NRP practice.

active comparator: DCC group

The OB provider will hold the baby at or below the level of placenta, provide warmth, stimulate the baby to breathe and suction the mouth/nose if needed for the first 30 seconds.

After these initial 30 seconds, if the baby is breathing then the obstetrician will continue DCC for a total of 60 seconds before clamping and cutting the cord close to the umbilicus and handing over the baby to the neonatal team for further stabilization as per standard NRP practice. If the baby is not breathing after the initial 30 seconds of DCC, then the OB provider will clamp and cut the cord close to the umbilicus and hand over the baby to the neonatal team to continue resuscitation of the baby as per the standard NRP guidelines.

Interventions

MOCC Group

After 30 seconds of DCC, the cord will be clamped and cut 5 cm from the introitus in vaginal delivery or abdominal incision in the case of cesarean section before passing the infant with the long umbilical cord segment to the pediatric provider who will milk the cord one time towards the baby during resuscitation.

DCC Group

The OB provider will hold the baby at or below the level of placenta, provide warmth, stimulate the baby to breathe and suction the mouth/nose if needed for the first 30 seconds.

After these initial 30 seconds, if the baby is breathing then the obstetrician will continue DCC for a total of 60 seconds before clamping and cutting the cord close to the umbilicus and handing over the baby to the neonatal team for further stabilization as per standard NRP practice. If the baby is not breathing after the initial 30 seconds of DCC, then the OB provider will clamp and cut the cord close to the umbilicus and hand over the baby to the neonatal team to continue resuscitation of the baby as per the standard NRP guidelines.

Primary outcome measure

  • Rate of compliance to the study intervention [ Time Frame: Two years ]
  • Number of patients completing the study [ Time Frame: Two years ]
  • Number of adverse events associated with the MOCC intervention [ Time Frame: Till the participants reach 2 year- corrected age (around 4.5 years) ]

Central Contacts and Locations

Central contacts

Walid El-Naggar, MD

902-470-7961walid.el-naggar@iwk.nshealth.ca

Jon Dorling, MD

902-470-6643Jon.Dorling@iwk.nshealth.ca

Locations

IWK Health Centre

Recruiting

Halifax, Nova Scotia, Canada, B3K 6R8

Contacts

Walid El-Naggar, MD

902-470-7961walid.el-naggar@iwk.nshealth.ca

Jon Dorling, MD

902-470-6643Jon.Dorling@iwk.nshealth.ca

More Information

Sponsor

IWK Health Centre

Last update posted

Feb 25, 2019

Last verified

Feb, 2019

Keywords

  • preterm infant
  • delayed cord clamping
  • cord milking
  • resuscitation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by IWK Health Centre on 2019-02-25.