Preterm InfantMOCCNCT03852134
Milking of the Cut-Cord During Resuscitation of Preterm Infants (The MOCC Study)
A study testing MOCC Group and DCC Group in people with Preterm Infant, run by IWK Health Centre at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages Up to 1 minute
- Conditions the study is for
- Preterm Infant
- What is being tested?
- MOCC Group and DCC Group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteCanada
- Study dates
- 7 Feb 2019to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 1 minute
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm infants <32 weeks' gestation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
IWK Health Centre
Halifax, Nova Scotia, B3K 6R8
Walid El-Naggar, MD, 902-470-7961, walid.el-naggar@iwk.nshealth.ca
Jon Dorling, MD, 902-470-6643, Jon.Dorling@iwk.nshealth.ca
About this study
Official title: Milking of the Cut-Cord During Resuscitation of Preterm Infants: A Randomized Controlled Trial (The MOCC Study)
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
- Being tested
- MOCC Group, DCC Group
- Keywords
- preterm infant, delayed cord clamping, cord milking, resuscitation
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOCC GroupProcedure or surgery
Also called Monitoring cerebral oxygenation by NIRS
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 GroupProcedure or surgery
Also called Monitoring cerebral oxygenation by NIRS
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.
| Study group | Role | What they receive |
|---|---|---|
| MOCC Group | Experimental | 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. Receives: Procedure: MOCC Group |
| DCC group | Active comparator | 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. Receives: Procedure: DCC Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Two years
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.
Measured: Two years
Number of adverse events associated with the MOCC intervention
To investigate any adverse events that could be attributed to the MOCC intervention.
Measured: Till the participants reach 2 year- corrected age (around 4.5 years)
Secondary outcomes (1)
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).
Measured: From date of randomization and assessed up to 24 hours of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2019
- Study start7 Feb 2019
- Primary completion7 Feb 2021 (estimated)
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preterm InfantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IWK Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walid El-Naggar, IWK Health Centre
- Investigators
- Walid El-Naggar, Principal investigator, IWK Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03852134
- Sponsor's protocol ID
- MOCC Study
- Acronym
- MOCC
- Status last verified
- Feb 2019
- First submitted
- 30 Apr 2018
- Last updated
- 25 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared
Publications
El-Naggar W, Mitra S, Abeysekera J, Disher T, Woolcott C, Hatfield T, McMillan D, Dorling J. Milking of the Cut Cord During Stabilization of Infants Born Very Premature: A Randomized Controlled Trial. J Pediatr. 2025 Mar;278:114444. doi: 10.1016/j.jpeds.2024.114444. Epub 2024 Dec 24.
PubMed 39722339
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Milking of the Cut-Cord During Resuscitation of Preterm Infants: A Randomized Controlled Trial (The MOCC Study)
- ClinicalTrials.gov ID
- NCT03852134
- Acronym / sponsor ID
- MOCC / MOCC Study
- Conditions
- Preterm Infant
- Keywords
- preterm infant, delayed cord clamping, cord milking, resuscitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- IWK Health CentreUniversity, hospital or other
- Study start
- 7 Feb 2019 (actual)
- Primary completion
- 7 Feb 2021 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 25 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MOCC Group | Experimental | Procedure: MOCC GroupThe 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. |
| DCC group | Active comparator | Procedure: DCC GroupThe 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. |
Who may qualify
- Ages
- Up to 1 minute
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Preterm infants <32 weeks' gestation
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MOCC GroupAlso: Monitoring cerebral oxygenation by NIRSAfter 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. | Procedure or surgery | MOCC Group |
| DCC GroupAlso: Monitoring cerebral oxygenation by NIRSThe 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. | Procedure or surgery | DCC group |
Primary outcome
Rate of compliance to the study intervention
Time frame: Two years
to investigate the adherence to the new approach of MOCC during resuscitation/ stabilization following 30 seconds of DCC in preterm infants.
Number of patients completing the study
Time frame: Two years
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.
Number of adverse events associated with the MOCC intervention
Time frame: Till the participants reach 2 year- corrected age (around 4.5 years)
To investigate any adverse events that could be attributed to the MOCC intervention.
1 secondary outcome
Compare hemoglobin (Hgb) concentration
Time frame: From date of randomization and assessed up to 24 hours of age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2019.
- Derived from this study: PubMed 39722339El-Naggar W, Mitra S, Abeysekera J, Disher T, Woolcott C, Hatfield T, McMillan D, Dorling J. Milking of the Cut Cord During Stabilization of Infants Born Very Premature: A Randomized Controlled Trial. J Pediatr. 2025 Mar;278:114444. doi: 10.1016/j.jpeds.2024.114444. Epub 2024 Dec 24.
- Individual participant dataSharing planned: No. IPD will not be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Walid El-Naggar principal investigator
IWK Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MOCC Group and DCC Group in people with Preterm Infant, run by IWK Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Walid El-Naggar, MD (902-470-7961, walid.el-naggar@iwk.nshealth.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of compliance to the study intervention (time frame: Two years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03852134, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2019.