Patterson Jackie K, Ishoso Daniel, Lokangaka Adrien, Iyer Pooja, Lowman Casey, Eilevstjønn Joar, Haug Ingunn, Kamath-Rayne Beena D, Mafuta Eric, Myklebust Helge, Nolen Tracy, Tshefu Antoinette, Bose Carl, Berkelhamer Sara
Department of Pediatrics, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States of America.
School of Public Health, University of Kinshasa, Kinshasa, Democratic Republic of Congo.
PLoS One. 2025 Jan 29;20(1):e0317199. doi: 10.1371/journal.pone.0317199. eCollection 2025.
To evaluate the impact of heart rate-guided basic resuscitation compared to Helping Babies Breathe on neonatal outcomes and resuscitation practices in the Democratic Republic of the Congo.
We conducted a pre-post clinical trial comparing heart rate-guided basic resuscitation to Helping Babies Breathe in three facilities, enrolling in-born neonates ≥28 weeks gestation. We collected observational data during a convenience sample of resuscitations and extracted clinical data from the medical record for all participants. We evaluated our primary outcome of effective breathing at three minutes after birth among newborns not breathing well at 30 seconds after birth employing generalized linear models using maximum likelihood estimation.
Among 1,284 newborns with observational data, there was no difference in the proportion effectively breathing at three minutes (adjusted relative risk 1.08 [95% CI 0.81, 1.45]). Among 145 receiving bag mask ventilation, time to bag mask ventilation decreased 64.3 seconds during heart rate-guided resuscitation (p<0.001). Among 10,906 enrolled in the trial, perinatal mortality was unchanged (adjusted relative risk 1.19 [95% CI 0.96, 1.48]) and death before discharge increased (adjusted relative risk 1.43 [95% CI 1.03, 1.99]). Expert review of stillborn cases demonstrated a stillbirth misclassification rate of 33.3% during Helping Babies Breathe versus 5.9% in heart rate-guided resuscitation.
During heart rate-guided basic resuscitation, time to bag mask ventilation was reduced by greater than one minute. The increase in death before discharge and unchanged perinatal mortality may be due to resuscitation of newborns with a higher risk of mortality who were previously presumed stillborn. A cluster-randomized trial of heart rate-guided basic resuscitation is needed to evaluate its impact on neonatal mortality in low-resource settings.
评估与“帮助婴儿呼吸”方法相比，心率指导下的基本复苏对刚果民主共和国新生儿结局及复苏实践的影响。
我们进行了一项前后对照临床试验，在三个机构中将心率指导下的基本复苏与“帮助婴儿呼吸”方法进行比较，纳入孕周≥28周的活产新生儿。我们在方便抽样的复苏过程中收集观察数据，并从所有参与者的病历中提取临床数据。我们采用最大似然估计的广义线性模型，评估出生后30秒呼吸不佳的新生儿出生后三分钟有效呼吸这一主要结局。
在1284例有观察数据的新生儿中，三分钟时有效呼吸的比例无差异（调整相对风险1.08 [95%置信区间0.81, 1.45]）。在145例接受面罩气囊通气的新生儿中，心率指导下的复苏过程中面罩气囊通气时间减少了64.3秒（p<0.001）。在10906例纳入试验的新生儿中，围产期死亡率未变（调整相对风险1.19 [95%置信区间0.96, 1.48]），出院前死亡增加（调整相对风险1.43 [95%置信区间1.03, 1.99]）。对死产病例的专家审查显示，“帮助婴儿呼吸”方法期间死产误分类率为33.3%，而心率指导下的复苏为5.9%。
在心率指导下的基本复苏过程中，面罩气囊通气时间减少了超过一分钟。出院前死亡增加和围产期死亡率未变可能是由于对先前被假定为死产但死亡风险较高的新生儿进行了复苏。需要进行一项心率指导下基本复苏的整群随机试验，以评估其在资源匮乏地区对新生儿死亡率的影响。
