Silveira Rita C, Valentini Nadia C, O'Shea T Michael, Mendes Eliane W, Froes Graciela, Cauduro Lenir, Panceri Carolina, Fuentefria Rubia N, Procianoy Renato S
Neonatal Section, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.
Programa de Pós-Graduação em Saúde da Criança e Adolescente, Federal University of Rio Grande do Sul, Porto Alegre, Brazil.
JAMA Netw Open. 2024 Jul 1;7(7):e2421896. doi: 10.1001/jamanetworkopen.2024.21896.
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).
To evaluate whether parent-guided early intervention improves the neurodevelopmental outcomes of preterm infants in an LMIC.
DESIGN, SETTING, AND PARTICIPANTS: 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.
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.
The primary outcome was the Bayley Scales of Infant and Toddler Development-Third Edition score at 18 months of age adjusted for prematurity.
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]).
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.
ClinicalTrials.gov Identifier: NCT02835612.
早期干预可改善早产后的神经发育结局，但针对家庭居住在低收入或中等收入国家（LMICs）的早产婴儿的早期干预研究较少。
评估家长指导的早期干预是否能改善LMICs中早产婴儿的神经发育结局。
设计、地点和参与者：这项随机临床试验在巴西一家高危产科转诊医院进行，由对随机分组情况不知情的检查人员进行结局评估。纳入标准为：（1）在研究医院出生；（2）居住在距出生医院40公里范围内；（3）胎龄小于32周或出生体重小于1500克。在138名登记婴儿中，19名在随机分组后死亡，19名退出研究；所有其他参与者（每个随机分组各50名）均接受了主要结局评估。数据收集时间为2016年1月1日至2022年5月31日，分析时间为2022年6月10日至7月31日。
在出生后第7天，婴儿被随机分为接受常规护理组（包括哺乳支持、袋鼠式护理和常规发育治疗）或家长指导的强化发育干预组（包括常规护理加上婴儿按摩以及强化视觉刺激、听觉刺激、社交互动和运动发育支持，由发育治疗师指导）。
主要结局是根据早产情况调整后的18月龄贝利婴幼儿发育量表第三版得分。
在纳入分析的100名婴儿中，平均（标准差）胎龄为28.4（2.2）周，57名（57%）为男性。干预组的平均（标准差）胎龄为28.3（2.3）周；常规护理组为28.5（2.2）周。干预组中女婴占21名（42%），常规护理组中女婴占22名（44%）；干预组男婴占29名（58%），常规护理组男婴占28名（56%）。强化发育干预组在矫正年龄18个月时的认知得分更高（平均[标准差]，101.8[11.9]对97.3[13.5]；平均差值，4.5[95%置信区间，0.1 - 8.9]）。
在这项针对LMICs中极早产或极低出生体重婴儿早期认知功能的家长指导发育干预的随机临床试验中，该干预改善了矫正年龄18个月时极早产婴儿的神经发育结局。家长指导的早期干预可改善LMICs中出生的极早产婴儿的神经发育结局。
ClinicalTrials.gov标识符：NCT02835612
