■早期干预可改善早产后的神经发育结果,但很少有早期干预的研究关注家庭居住在低收入或中等收入国家(LMICs)的早产儿.
■评估父母指导的早期干预是否能改善LMIC中早产儿的神经发育结果。
这项随机临床试验是在巴西一家高危产科转诊医院进行的,考官对随机分组的结果评估被掩盖。合格标准是(1)在研究医院出生,(2)居住在出生医院40公里以内,(3)胎龄小于32周或出生体重小于1500克。在138名入组婴儿中,19人在随机分组后死亡,19人退出研究;所有其他参与者(每个随机分组50人)都进行了主要结果评估。数据从2016年1月1日至2022年5月31日收集,并从2022年6月10日至7月31日进行分析。
■在出生后第7天,婴儿被随机分配到常规护理,包括对泌乳的支持,袋鼠护理,和常规的发育疗法,或者父母指导的强化发展干预,包括常规护理加上婴儿按摩和增强的视觉刺激,听觉刺激,社交互动,以及对电机发展的支持,由发展治疗师指导。
■主要结果是根据早产调整的18月龄Bayley婴儿和幼儿发育量表-第三版评分。
■在分析中包括的100名婴儿中,平均(SD)胎龄为28.4(2.2)周,57(57%)为男性。干预组的平均(SD)胎龄为28.3(2.3)周;对于常规护理组,28.5(2.2)周。干预组女婴占21例(42%),常规护理组22例(44%);男婴,29(58%)和28(56%),分别。强化发育干预组在校正年龄18个月时的认知评分较高(平均值[SD],101.8[11.9]对97.3[13.5];平均差,4.5[95%CI,0.1-8.9])。
■在这项在LMIC中实施的针对早产或极低出生体重婴儿的早期认知功能的父母指导的发育干预的随机临床试验中,干预措施改善了18个月调整年龄的极早产儿的神经发育结局.父母指导的早期干预可以改善LMIC出生的早产儿的神经发育结局。
■ClinicalTrials.gov标识符:NCT02835612。
UNASSIGNED: Early interventions improve neurodevelopmental outcomes after preterm birth, but few studies of early intervention have focused on preterm infants whose families reside in low- or middle-income countries (LMICs).
UNASSIGNED: To evaluate whether parent-guided early intervention improves the neurodevelopmental outcomes of preterm infants in an LMIC.
UNASSIGNED: This randomized clinical trial was performed at a high-risk obstetric referral hospital in Brazil, with outcome evaluations by examiners masked to randomization group. Eligibility criteria were (1) birth at the study hospital, (2) residence within 40 km of the birth hospital, and (3) gestational age of less than 32 weeks or birth weight of less than 1500 g. Of 138 enrolled infants, 19 died after randomization and 19 withdrew from the study; all other enrollees (50 per randomization group) were evaluated for the primary outcome. Data were collected from January 1, 2016, to May 31, 2022, and analyzed from June 10 to July 31, 2022.
UNASSIGNED: On postnatal day 7, infants were randomized to usual care, consisting of support for lactation, kangaroo care, and routine developmental therapies, or to a parent-guided enhanced developmental intervention, consisting of usual care plus infant massage and enhanced visual stimulation, auditory stimulation, social interactions, and support for motor development, instructed by developmental therapists.
UNASSIGNED: The primary outcome was the Bayley Scales of Infant and Toddler Development-Third Edition score at 18 months of age adjusted for prematurity.
UNASSIGNED: Among the 100 infants included in the analysis, mean (SD) gestational age was 28.4 (2.2) weeks, and 57 (57%) were male. The mean (SD) gestational age for the intervention group was 28.3 (2.3) weeks; for the usual care group, 28.5 (2.2) weeks. Female infants accounted for 21 infants (42%) of the intervention group and 22 (44%) of the usual care group; male infants, 29 (58%) and 28 (56%), respectively. The enhanced developmental intervention group had higher cognitive scores at 18 months of corrected age (mean [SD], 101.8 [11.9] vs 97.3 [13.5]; mean difference, 4.5 [95% CI, 0.1-8.9]).
UNASSIGNED: In this randomized clinical trial of a parent-guided developmental intervention for early cognitive function of very preterm or very low birth weight infants implemented in an LMIC, the intervention improved very preterm infants\' neurodevelopmental outcomes at 18 months of adjusted age. Parent-guided early intervention can improve neurodevelopmental outcome of very preterm infants born in LMICs.
UNASSIGNED: ClinicalTrials.gov Identifier: NCT02835612.