Intraventricular Hemorrhage, PreTerm Birth
Conditions
Brief summary
For preterm infants, deferred cord clamping has been shown to improve both short term and long-term neonatal outcomes without an established harm for both the mother and her infant.The interference with resuscitative measures for the neonate or the mother is a risk that continued to hamper the implementation of delayed cord clamping in many centers around the world.For that reason, the evidence now is seeking a time-honored, yet not adopted method of placental transfusion that involves milking of the umbilical cord.
Detailed description
Contrary to delayed cord clamping, milking of the umbilical cord is done at a faster rate and in shorter time.Recent evidence has demonstrated the efficacy and safety of umbilical cord milking for both term and preterm infants.A newer evidence comparing delayed cord clamping to umbilical cord milking in preterm infants demonstrated a higher initial hemoglobin, blood pressure and systemic blood flow in preterm infants allocated to the umbilical cord milking arm.However, concerns have been raised with regard to rapid infusion of large volume of blood in relatively shorter time predisposing to hyperperfusion injury including intraventricular hemorrhage. This is particularly problematic for preterm neonates as they are at higher risk of neurological injury. It has, though, advantage of shorter timeframe allowing for effective resuscitation of preterm neonates to start as soon as possible. Thus, with countering advantages and disadvantages, the practice has not been adopted at most places. The authors planned to conduct a randomized clinical trail to compare the efficacy and safety of umbilical cord milking to deferred cord clamping in preterm infants less than 32 weeks gestation.
Interventions
OTHERUmbilical cord milking
Milking of the umbilical cord at delivery
Sponsors
King Abdulaziz University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Preterm infants \< 32 weeks gestation confirmed by first trimester US
Exclusion criteria
* Any proven or suspected congenital or chromosomal abnormalities * Placenta previa or abruption * Cord prolapse * Known Rh sensitization * Fetal hydrops * Monochorionic multiples
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraventricular haemorrhage | twenty eight days | Any IVH diagnosed by cranial ultrasound |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Venous Hgb | 2 days | Hgb at birth |
| Venous hematocrit | 2 days | Hematocrit at birth |
| Bilirubin level | 24 hours after birth | First bilirubin level after birth |
| Maximum bilirubin level | first week of life | Highest bilirubin level |
| Need for resuscitation | one hour | Cardiac compression or medications at birth |
| Apgar score at one minute | one minute after delivery | Calculated Apgar score at one minute |
| Apgar score at 5 minutes | 5 minutes after delivery | Calculated Apgar score at 5 minutes |
| Polycythemia | first 48 hours after birth | If venous hematocrit more than 65% |
| Respiratory distress syndrome | 48 hours after birth | The need for surfactant administration |
| The need for blood transfusion during hospital stay | one month | The number of blood transfusions during hospital stay |
| Need for volume administration | 24 hours after birth | Need for bolus administration first 24 hours after birth |
| Use of inotropes | First 24 hours | Use of any kind of inotropes in the first 24 hours |
| Necrotizing enterocolitis | one month | Bell stage II or more |
| Mortality in hospital | one month | Death before discharge |
| Sepsis | one month | Positive blood culture |
| Maternal mortality | 2 weeks | Maternal death after delivery in hospital |
| Post partum hemorrhage | one day | Maternal estimated blood loss more than 500 mls in the first 24 hours after birth |
| Maternal need for blood transfusion | First 48 hours after delivery | Maternal blood transfusion in the first 48 hours after delivery |
| Length of third stage | 24 hours | The time from delivery of the infant until delivery of placenta |
| Oxygen dependency | first 28 days after birth and 36 weeks corrected age | first 28 days after birth and/or 36 weeks corrected age |
Countries
Saudi Arabia
Contacts
Primary ContactHeidi Al-Wassia
Outcome results
None listed