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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MOCC Group | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Temperature stability | Temperature on admission to NICU | From randomization assessed up to 2 hours of age |
| Need for advanced resuscitation at birth | Need for advanced resuscitation including intubation, chest compressions and/or medications |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Walid El-Naggar, MD | Contact | 902-470-7961 | walid.el-naggar@iwk.nshealth.ca | |
| Jon Dorling, MD | Contact | 902-470-6643 | Jon.Dorling@iwk.nshealth.ca |
| Name | Affiliation | Role |
|---|---|---|
| Walid El-Naggar | IWK Health Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IWK Health Centre | Recruiting | Halifax | Nova Scotia | B3K 6R8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39722339 | Derived | 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. |
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IPD will not be shared
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| DCC Group | Procedure | 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. |
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| From randomization assessed up to 2 hours of age |
| Inotropic support | Need for inotropic medication support | From randomization assessed up to 72 hours of age |
| Volume expander | Assess the need for a volume expander (saline bolus or albumin bolus) | From randomization assessed up to 72 hours of age |
| Cerebral oxygenation | Measure the cerebral oxygenation using NIRS | From randomization assessed up to 72 hours of age |
| Blood transfusion | Assess the number of blood transfusions baby received from birth | From randomization assessed up to 36 weeks corrected gestational age |
| Intraventricular hemorrhage (IVH) | Assess the grade of IVH | From randomization assessed up to 36 weeks corrected age |
| Long-term outcomes | Long-term neurodevelopmental outcomes at 18-24 months of corrected age. | 24 Months Corrected age |
| D000091642 | Urogenital Diseases |