Mortality was more than twice as high in out-of-hospital deliveries than for in-hospital matched controls. Hypothermia was an important associated risk factor. Measures such as oxygen administration to maintain an appropriate saturation for gestational age, the provision of polyethylene plastic wraps and skin-to-skin contact are recommended.
Background Preterm prelabor rupture of membranes (PPROM) before 34 weeks of gestation complicates 1% of pregnancies and accounts for one-third of preterm births. International guidelines recommend expectant management, along with antenatal steroids before 34 weeks and antibiotics. Up-to-date evidence about the risks and benefits of administering tocolysis after PPROM, however, is lacking. In theory, reducing uterine contractility could delay delivery and reduce the risks of prematurity and its adverse short- and long-term consequences, but it might also prolong fetal exposure to inflammation, infection, and acute obstetric complications, potentially associated with neonatal death or long-term sequelae. The primary objective of this study is to assess whether short-term (48 h) tocolysis reduces perinatal mortality/morbidity in PPROM at 22 to 33 completed weeks of gestation. Methods A randomized, double-blind, placebo-controlled, superiority trial will be performed in 29 French maternity units. Women with PPROM between 220/7 and 336/7 weeks of gestation, a singleton pregnancy, and no condition contraindicating expectant management will be randomized to receive a 48-hour oral treatment by either nifedipine or placebo (1:1 ratio). The primary outcome will be the occurrence of perinatal mortality/morbidity, a composite outcome including fetal death, neonatal death, or severe neonatal morbidity before discharge. If we assume an alpha-risk of 0.05 and beta-risk of 0.20 (i.e., a statistical power of 80%), 702 women (351 per arm) are required to show a reduction of the primary endpoint from 35% (placebo group) to 25% (nifedipine group). We plan to increase the required number of subjects by 20%, to replace any patients who leave the study early. The total number of subjects required is thus 850. Data will be analyzed by the intention-to-treat principle. Discussion This trial will inform practices and policies worldwide. Optimized prenatal management to improve the prognosis of infants born preterm could benefit about 50,000 women in the European Union and 40,000 in the United States each year. Trial registration ClinicalTrials.gov identifier: NCT03976063 (registration date June 5, 2019).
Background: Roughly 10% of newborns need help to complete the transition of birth. For these infants, international guidelines recommend supporting them using a 4-step procedure (A to D). Step A is an assessment time, which includes eight tasks and finishes by starting the positive pressure ventilation (PPV), if necessary (step B). The guidelines changed in 2015 and the allotted time was raised from 30 to 60 seconds for step A completion. This study aimed to assess if the reduced time constraint in step A could have an impact on 1st-year pediatric residents' performance to complete step A and if could lead to later initiation of step A. Methods: Using video recordings of standardized neonatal scenarios over 6 years (3 before the change and 3 after), we assessed the ability of 1st-year pediatric residents of the Paris region to complete step A and initiate PPV in the allotted time in each period. Among the sessions, including at least five scenarios we evaluated all the PPV required scenarios executed for the first time by a dyad of 1st-year pediatric residents. Results: Among 52 sessions, we included 104 scenarios (25 sessions and 50 scenarios before the change and 27 sessions and 54 scenarios after). PPV started roughly at 1-minute resuscitation in both periods, but completion of the tasks before PPV-start was significant. Only 12% of the dyad of residents executed the eight tasks before PPV initiation in the first period versus 54% in the second period (p < 0.0001). Additionally, the completion of the eight tasks of step A was significantly better during the second period (6 [6-7] vs. 8 [7-8] p < 0.001). Conclusions:: These results could suggest that a reduced time constraint for step A imposed by the new Guidelines was associated with better performance.
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