Using a WeChat mini-program-based lactation consultant intervention to increase the consumption of mother's own milk by preterm infants in the neonatal intensive care unit: a study protocol for a cluster randomized controlled trial

Jie Huo, Xinping Wu, Chuanli Gu, Zhangbin Yu, Jun Zhang, Xiaohui Chen, Jingai Zhu, Feng Liu, Beibei Liu, Qianqian Li, Shuping Han, Jie Huo, Xinping Wu, Chuanli Gu, Zhangbin Yu, Jun Zhang, Xiaohui Chen, Jingai Zhu, Feng Liu, Beibei Liu, Qianqian Li, Shuping Han

Abstract

Background: 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).

Discussion: 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.

Trial registration: ClinicalTrials.gov NCT04383379. Registered on May 5, 2020.

Keywords: Lactation consultant; Mother’s own milk feeding; Premature infant; Randomized controlled trial; WeChat mini-programs.

Conflict of interest statement

All authors declare that there are no conflicts of interest related to this study.

© 2021. The Author(s).

Figures

Fig. 1
Fig. 1
Study protocol flowchart of MOM feeding lactation consultant intervention via WeChat mini-programs
Fig. 2
Fig. 2
Schedule of enrolment, interventions, and assessments
Fig. 3
Fig. 3
Function of instructions for the “Ning BX breastfeeding” WeChat mini-programs

References

    1. Manzoni P, Stolfi I, Pedicino R, Vagnarelli F, Mosca F, Pugni L, Bollani L, Pozzi M, Gomez K, Tzialla C, Borghesi A, Decembrino L, Mostert M, Latino MA, Priolo C, Galletto P, Gallo E, Rizzollo S, Tavella E, Luparia M, Corona G, Barberi I, Tridapalli E, Faldella G, Vetrano G, Memo L, Saia OS, Bordignon L, Messner H, Cattani S, Della Casa E, Laforgia N, Quercia M, Romeo M, Betta PM, Rinaldi M, Magaldi R, Maule M, Stronati M, Farina D, Italian Task Force for the Study and Prevention of Neonatal Fungal Infections, Italian Society of Neonatology Human milk feeding prevents retinopathy of prematurity (ROP) in preterm VLBW neonates[J] Early Hum Dev. 2013;89(Suppl 1):S64–S68. doi: 10.1016/S0378-3782(13)70019-7.
    1. Alshaikh B, Kostecky L, Blachly N, Yee W. Effect of a quality improvement project to use exclusive mother’s own milk on rate of necrotizing enterocolitis in preterm infants[J] Breastfeed Med. 2015;10(7):355–361. doi: 10.1089/bfm.2015.0042.
    1. Sullivan S, Schanler RJ, Kim JH, Patel AL, Trawöger R, Kiechl-Kohlendorfer U, Chan GM, Blanco CL, Abrams S, Cotten CM, Laroia N, Ehrenkranz RA, Dudell G, Cristofalo EA, Meier P, Lee ML, Rechtman DJ, Lucas A. An exclusively human milk-based diet is associated with a lower rate of necrotizing enterocolitis than a diet of human milk and bovine milk-based products[J] J Pediatr. 2010;156(4):562–567. doi: 10.1016/j.jpeds.2009.10.040.
    1. Meier PP. Human milk and clinical outcomes in preterm infants[J] Nestle Nutr Inst Workshop Ser. 2019;90:163–174. doi: 10.1159/000490304.
    1. Duijts L, Jaddoe VW, Hofman A, et al. Prolonged and exclusive breastfeeding reduces the risk of infectious diseases in infancy[J] Pediatrics. 2010;126(1):e18–e25. doi: 10.1542/peds.2008-3256.
    1. Kim LY, Mcgrath-Morrow SA, Collaco JM. Impact of breast milk on respiratory outcomes in infants with bronchopulmonary dysplasia[J] Pediatr Pulmonol. 2019;54(3):313–318. doi: 10.1002/ppul.24228.
    1. Corpeleijn WE, Kouwenhoven SMP, Paap MC, van Vliet I, Scheerder I, Muizer Y, Helder OK, van Goudoever JB, Vermeulen MJ. Intake of own mother’s milk during the first days of life is associated with decreased morbidity and mortality in very low birth weight infants during the first 60 days of life[J] Neonatology. 2012;102(4):276–281. doi: 10.1159/000341335.
    1. Vohr BR, Poindexter BB, Dusick AM, McKinley LT, Wright LL, Langer JC, Poole WK, for the NICHD Neonatal Research Network Beneficial effects of breast milk in the neonatal intensive care unit on the developmental outcome of extremely low birth weight infants at 18 months of age[J] Pediatrics. 2006;118(1):e115–e123. doi: 10.1542/peds.2005-2382.
    1. Petersen R. A 2017 Update: Centers for disease control and prevention’s contributions and investments in breastfeeding[J] Breastfeed Med. 2017;12(8):465–467. doi: 10.1089/bfm.2017.0093.
    1. Wang DH. Multicenter study of the nutritional status of premature infants in neonatal intensive care unit in China: report of 974 cases. Zhonghua Er Ke Za Zhi. 2009;47(1):12–17.
    1. US Department of Health and Human Services. Healthy People 2010, Volumes I and II. Washington, DC: US Dept of Health and Human Services, Public Health Service, Office of the Assistant Secretary for Health; 2000.[J].
    1. Ryan AS, Wenjun Z, Acosta A. Breastfeeding continues to increase into the new millennium[J] Pediatrics. 2002;110(6):1103–1109. doi: 10.1542/peds.110.6.1103.
    1. Patnode CD, Henninger ML, Senger CA, et al. Primary care interventions to support breastfeeding: updated evidence report and systematic review for the US preventive services task force[J] JAMA. 2016;316(16):1694–1705. doi: 10.1001/jama.2016.8882.
    1. Liu P, Qiao L, Xu F, Zhang M, Wang Y, Binns CW. Factors associated with breastfeeding duration: a 30-month cohort study in northwest China[J] J Hum Lact. 2013;29(2):253–259. doi: 10.1177/0890334413477240.
    1. Huang P, Ren J, Liu Y, et al. Factors affecting breastfeeding adherence among Chinese mothers: a multicenter study[J] Medicine (Baltimore) 2017;96(38):e7619. doi: 10.1097/MD.0000000000007619.
    1. Sun K, Chen M, Yin Y, Wu L, Gao L. Why Chinese mothers stop breastfeeding: mothers’ self-reported reasons for stopping during the first six months[J] J Child Health Care. 2017;21(3):353–363. doi: 10.1177/1367493517719160.
    1. García-Gómez JM, de la Torre-Díez I, Vicente J, et al. Analysis of mobile health applications for a broad spectrum of consumers: a user experience approach[J] Health Informatics J. 2014;20(1):74–84. doi: 10.1177/1460458213479598.
    1. Giglia R, Cox K, Zhao Y, Binns CW. Exclusive breastfeeding increased by an internet intervention[J] Breastfeed Med. 2015;10(1):20–25. doi: 10.1089/bfm.2014.0093.
    1. White B, Giglia RC, White JA, Dhaliwal S, Burns SK, Scott JA. Gamifying Breastfeeding for fathers: process evaluation of the milk man mobile app[J] JMIR Pediatr Parent. 2019;2(1):e12157. doi: 10.2196/12157.
    1. Smith C. 110 amazing WeChat statistics and facts (2020) 2020.
    1. Michalek, and Joel. "Chul Ahn, Moonseong Heo and Song Zhang. Sample size calculations for clustered and longitudinal outcomes in clinical research. Boca Raton, CRC Press. " Biometrics 74.1(2018):379-379..
    1. Campbell, Michael J. , and S. J. Walters . How to design, analyse and report cluster randomised trials in medicine and health related research (Campbell/How to Design, Analyse and Report Cluster Randomised Trials in Medicine and Health Related Research) || Statistics in Practice. John Wiley & Sons, Ltd, 2014.
    1. Bigger HR, Fogg LJ, Patel A, Johnson T, Engstrom JL, Meier PP. Quality indicators for human milk use in very low-birthweight infants: are we measuring what we should be measuring? J Perinatol. 2014 Apr;34(4):287-291. doi: 10.1038/jp.2014.5. Epub 2014 Feb 13. PMID: 24526005; PMCID: PMC3969767.
    1. Shao X, Ye H, Qiu X. Practical neonatology [M]. Version 4. Beijing: People Health Press; 2011.
    1. Fernández Medina IM, Fernández-Sola C, López-Rodríguez MM, Hernández-Padilla JM, Jiménez Lasserrotte MDM, Granero-Molina J. Barriers to providing mother’s own milk to extremely preterm infants in the NICU. Adv Neonatal Care. 2019;19(5):349-360. doi: 10.1097/ANC.0000000000000652. PMID: 31651469.
    1. Zhou Q, Zhang L, Lee SK, Chen C, Hu XJ, Liu C, Cao Y. A quality improvement initiative to increase mother’s own milk use in a Chinese neonatal intensive care unit. Breastfeed Med. 2020;15(4):261-267. doi: 10.1089/bfm.2019.0290. Epub 2020 Mar 4. PMID: 32129666.

Source: PubMed

Sponsors and Collaborators

Medical Conditions

Drug Interventions

3
Subscribe