Milking of the Cut-Cord During Resuscitation of Preterm Infants (The MOCC Study)

Preterm Infant Clinical Trial

— MOCC  

Official title:

Milking of the Cut-Cord During Resuscitation of Preterm Infants: A Randomized Controlled Trial (The MOCC Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03852134
• Other study ID #: MOCC Study
• Status: Recruiting
• Phase: N/A
• Start date: February 7, 2019
• Est. completion date: July 31, 2023

Study information

• Verified date: February 2019
• Source: IWK Health Centre
• Contact: Walid El-Naggar, MD
• Phone: 902-470-7961
• Email: walid.el-naggar[@]iwk.nshealth.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 98
• Est. completion date: July 31, 2023
• Est. primary completion date: February 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Minute

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Preterm Infant

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Canada	IWK Health Centre	Halifax	Nova Scotia

Sponsors (1)

Lead Sponsor	Collaborator
IWK Health Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Temperature stability	Temperature on admission to NICU	From randomization assessed up to 2 hours of age
Other	Need for advanced resuscitation at birth	Need for advanced resuscitation including intubation, chest compressions and/or medications	From randomization assessed up to 2 hours of age
Other	Inotropic support	Need for inotropic medication support	From randomization assessed up to 72 hours of age
Other	Volume expander	Assess the need for a volume expander (saline bolus or albumin bolus)	From randomization assessed up to 72 hours of age
Other	Cerebral oxygenation	Measure the cerebral oxygenation using NIRS	From randomization assessed up to 72 hours of age
Other	Blood transfusion	Assess the number of blood transfusions baby received from birth	From randomization assessed up to 36 weeks corrected gestational age
Other	Intraventricular hemorrhage (IVH)	Assess the grade of IVH	From randomization assessed up to 36 weeks corrected age
Other	Long-term outcomes	Long-term neurodevelopmental outcomes at 18-24 months of corrected age.	24 Months Corrected age
Primary	Rate of compliance to the study intervention	to investigate the adherence to the new approach of MOCC during resuscitation/ stabilization following 30 seconds of DCC in preterm infants.	Two years
Primary	Number of patients completing the study	To evaluate the number of patients who are recruited and completed the study to estimate the sample size needed for the design of a large multi-centre RCT.	Two years
Primary	Number of adverse events associated with the MOCC intervention	To investigate any adverse events that could be attributed to the MOCC intervention.	Till the participants reach 2 year- corrected age (around 4.5 years)
Secondary	Compare hemoglobin (Hgb) concentration	to compare hemoglobin (Hgb) concentration on NICU admission in preterm infants <32 weeks' gestation who receive MOCC during resuscitation/stabilization following 30 seconds of DCC with those who receive DCC alone for 30-60 seconds at birth (standard practice-control group).	From date of randomization and assessed up to 24 hours of age