PCI-T
Trial question
What is the role of resuscitation with intact placental circulation in preterm infants at 23-29 weeks of gestational age?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
43.0% female
57.0% male
N = 209
209 patients (90 female, 119 male).
Inclusion criteria: preterm infants at 23-29 weeks of gestational age born from singleton pregnancies.
Key exclusion criteria: twin or multiple births; placental or cord abnormalities; major congenital malformations; hydrops fetalis; maternal severe compromise at delivery.
Interventions
N=105 resuscitation with intact placental circulation (cord clamped at 180 seconds at birth without milking, followed by resuscitation if needed).
N=104 resuscitation with umbilical cord milking (20 cm of the intact cord squeezed over 2 seconds, repeated for a total of 4 times, and then clamped and cut within 20 seconds of life, followed by resuscitation if needed).
Primary outcome
Death, grade 3-4 intraventricular hemorrhage, and bronchopulmonary dysplasia at 36 weeks of postconception age
33%
38%
38.0 %
28.5 %
19.0 %
9.5 %
0.0 %
Resuscitation with intact placental
circulation
Resuscitation with umbilical cord
milking
No significant
difference ↔
No significant difference in death, grade 3-4 intraventricular hemorrhage, and bronchopulmonary dysplasia at 36 weeks of postconception age (33% vs. 38%; OR 0.83, 95% CI 0.47 to 1.47).
Secondary outcomes
No significant difference in death (16% vs. 24%; OR 0.6, 95% CI 0.2 to 1.73).
No significant difference in bronchopulmonary dysplasia (39% vs. 35%; OR 1.18, 95% CI 0.5 to 2.81).
No significant difference in mechanical ventilation (57% vs. 47%; AD 10%, 95% CI -3.27 to 23.27).
Conclusion
In preterm infants at 23-29 weeks of gestational age born from singleton pregnancies, resuscitation with intact placental circulation was not superior to resuscitation with umbilical cord milking with respect to death, grade 3-4 intraventricular hemorrhage, and bronchopulmonary dysplasia at 36 weeks of postconception age.
Reference
Simone Pratesi, Martina Ciarcià, Luca Boni et al. Resuscitation With Placental Circulation Intact Compared With Cord Milking: A Randomized Clinical Trial. JAMA Netw Open. 2024 Dec 2;7(12):e2450476.
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