Department of Neonatology, Yangzhou Maternity and Child Health Care Hospital, Yangzhou, 225002, China.
Department of Neonatology, Nanjing Maternity and Child Health Care Hospital, Nanjing Medical University, Nanjing, 210004, China.
Trials. 2021 Nov 24;22(1):834. doi: 10.1186/s13063-021-05731-6.
The benefits of mother's own milk (MOM) for preterm infants have been widely recognized. Many studies have shown that the rate of breastfeeding of premature infants remains very low. Although many studies use measures to promote breastfeeding, few high-quality cluster randomized controlled studies have evaluated the effectiveness of these measures. WeChat is an instant messaging software for smart terminals, and WeChat mini-programs have been widely used to promote health and self-management in China. Based on this background, we designed a randomized controlled study based on WeChat mini-programs to promote MOM feeding of premature infants in the neonatal intensive care unit (NICU).
METHODS/DESIGN: This study will evaluate the effectiveness of WeChat mini-programs to increase the consumption of MOM feeding in twelve NICUs in Jiangsu Province, namely, six "intervention" NICUs and six "control" NICUs. The study process is as follows: (1) design and preparation, (2) NICU recruitment and training, (3) interpretation and analysis of baseline data, (4) quality control implementation process, and (5) data analysis feedback and publication of study reports. The primary outcome is the proportion of MOM feeding of premature infants during NICU hospitalization. The secondary outcomes are as follows: (1) time to initiation of MOM feeding (hours) and proportion of first-time MOM feeding (%), (2) duration of parenteral nutrition (days), (3) time to total gastrointestinal feeding (days), (4) hospitalization time and hospitalization cost, and (5) incidence of complications (necrotizing enterocolitis, bronchopulmonary dysplasia, feeding intolerance, late-onset sepsis, retinopathy of prematurity).
This study is the first cluster randomized controlled trial on the intervention of using a WeChat mini-program-based lactation consultant for premature infants in the NICU in China. We hope this study can improve the consumption of MOM by NICU premature infants during hospitalization through the intervention of WeChat mini-programs.
ClinicalTrials.gov NCT04383379. Registered on May 5, 2020.
母乳喂养（MOM）对早产儿的益处已得到广泛认可。许多研究表明，早产儿的母乳喂养率仍然非常低。尽管许多研究都采用了促进母乳喂养的措施，但很少有高质量的群组随机对照研究评估这些措施的有效性。微信是一种适用于智能终端的即时通讯软件，微信小程序在中国已被广泛用于促进健康和自我管理。基于这一背景，我们设计了一项基于微信小程序的群组随机对照研究，以促进新生儿重症监护病房（NICU）中早产儿的 MOM 喂养。
方法/设计：这项研究将评估微信小程序在江苏省 12 家 NICU 中增加 MOM 喂养量的效果，即 6 家“干预”NICU 和 6 家“对照”NICU。研究过程如下：（1）设计和准备，（2）NICU 招募和培训，（3）解释和分析基线数据，（4）实施质量控制过程，以及（5）数据分析反馈和研究报告发表。主要结局是 NICU 住院期间早产儿 MOM 喂养的比例。次要结局如下：（1）MOM 喂养开始时间（小时）和首次 MOM 喂养比例（%），（2）肠外营养时间（天），（3）全胃肠喂养时间（天），（4）住院时间和住院费用，以及（5）并发症发生率（坏死性小肠结肠炎、支气管肺发育不良、喂养不耐受、晚发性败血症、早产儿视网膜病变）。
这是中国首例基于微信小程序的新生儿重症监护病房中早产儿哺乳顾问干预的群组随机对照试验。我们希望这项研究可以通过微信小程序的干预，提高 NICU 早产儿住院期间 MOM 的摄入量。
ClinicalTrials.gov NCT04383379。注册于 2020 年 5 月 5 日。
