Due to immature organ development, preterm infants require specialized care in the Neonatal Intensive Care Unit (NICU) [1]. The therapeutic needs along with certain environmental factors [2-6], lead to premature infants being exposed to various stressors in the NICU [7-11]. These stressors not only interfere with the neurodevelopment and growth of premature infants, affecting their short-term and long-term neurodevelopment and outcomes but may also cause negative emotions such as anxiety and depression in the parents [2-6].
Kangaroo Mother Care (KMC) is a method of caring for premature and low birth weight infants, involving continuous skin-to-skin contact with the mother's chest and promoting breastfeeding as much as possible. KMC can reduce the impact of NICU-related stressors. However, our previous study [13] found various issues in evaluating the effectiveness of KMC. These problems include significant differences in outcome defined and selection, unreported or incompletely reported major outcomes diverse outcome measurement tools or methods selection, and even the absence of reporting on the tools or methods used for outcome measurement. These issues have hindered many KMC-related clinical studies from providing precise evidence for applying KMC in various contexts. This inability to support data synthesis and evidence-based decision-making has somewhat diminished the value of KMC research and wasted research funds. The heterogeneity in reported outcomes may also suggest the possibility of outcome-selective reporting bias.
Two relevant protocols have been registered with the COMET initiative, with the goal of developing a core outcome set for neonatal research (registration number: 842) and family-centred care (registration title: Developing a Core Outcome Set and outcome measures of family-centred care In Neonatal care: COUSIN study). However, it is important to note that neither of these protocols specifically focuses on KMC. They differ in their definitions and content. Moreover, applying the core outcomes of these studies to evaluate KMC is not feasible. Currently, there is no core outcome set established for KMC practice.
Consequently, this study proposes the construction of a core outcome set for KMC, aiming to promote standardization and systematization in the evaluating KMC effectiveness. This initiative intends to enhance sensitivity, increase comparability among similar studies, provide high-quality clinical evidence for clinical research, reduce research resource wastage, and promote the development and dissemination of clinical research on KMC.
Aim:
To develop a core outcome set and a set of outcome measures and recommended time points to evaluate KMC practices in neonatal care.
Objectives:
1. To identify outcomes and outcome instruments reported in studies evaluating KMC. (Systematic review)
2. To establish a core outcome set for KMC. (consensus process )
3. To reach a consensus on the core outcome measurement for KMC studies. (consensus process)
Impact:
This project will create a core outcome set for KMC to guide future research in neonatal care. This initiative intends to enhance sensitivity and increase comparability among similar studies, which can support data synthesis and evidence-based decision-making, reduce research resource wastage, and promote the development and dissemination of clinical research on KMC.
Reference
[1] Yue, S., Zhang, J., Ma, D. (2019). Advances in Research on the Impact of Neonatal Intensive Care Unit Environmental Stress on Premature Infant Neurodevelopment and Epigenetics. Zhong Guo Dang Dai Er Ke Za Zhi, 2019; 21(11), 1144-1147.
[2] Pavlyshyn H, Sarapuk I, Horishna I ,et al. Skin-to-skin contact to support preterm infants and reduce NICU-related stress. Int J Dev Neurosci, 2022; 82(7):639-645.
[3] Mariani Wigley ILC, Mascheroni E, et al. The role of maternal touch in the association between SLC6A4 methylation and stress response in very preterm infants. Dev Psychobiol, 2021; 63(Suppl 1):e22218.
[4] Campbell-Yeo M, Eriksson M, Benoit B. Assessment and Management of Pain in Preterm Infants: A Practice Update. Children (Basel). 2022; 9(2):244.
[5] Altimier, L., & Phillips, R. M. The neonatal integrative developmental care model: Seven neuroprotective core measures for family-centered developmental care. Newborn and Infant Nursing Reviews, 2013; 13(1), 9-22.
[6] Chau, V., Synnes, A., Grunau, R. E., et al. Abnormal brain maturation in preterm neonates associated with adverse developmental outcomes. Neurology, 2013; 81, 2082-2089.
[7] Mooney-Leber SM, Brummelte S. Neonatal pain and reduced maternal care: Early-life stressors interacting to impact brain and behavioral development. Neuroscience. 2017; 342:21-36.
[9] Salavitabar, A., Haidet, K. K., Adkins, C. S., et al. Preterm infants’ sympathetic arousal and associated behavioral responses to sound stimuli in the neonatal intensive care unit. Adv Neonatal Care, 2010; 10(3), 158-166.
[10] Als, H., Duffy, F. H., McAnulty, G. B., et al. Early experience alters brain function and structure. Pediatrics, 2004; 113(4): 846-857.
[11] Smith, G. C., Gutovich, J., Smyser, C., et al. Neonatal intensive care unit stress is associated with brain development in preterm infants. Ann Neurol,2011; 70(4):541-549.
[12] Li YX, Hu YL, Chen Q, et al. Clinical practice guideline for kangaroo mother care in preterm and low birth weight infants. J Evid Based Med. 2022;15(4):408-424.
Ying Xin Li. West China Second University Hospital, Sichuan University, Sichuan, China
yingxin-li@scu.edu.cn
Xia Li. West China Second University Hospital, Sichuan University, Sichuan, China
Yuan Li. West China Second University Hospital, Sichuan University, Sichuan, China
Xue Mei Guo. West China Second University Hospital, Sichuan University, Sichuan, China
Ru Yang. West China Second University Hospital, Sichuan University, Sichuan, China
Han Mei Peng. West China Second University Hospital, Sichuan University, Sichuan, China
Xi Huang. West China Second University Hospital, Sichuan University, Sichuan, China
Qiong Cheng. West China Second University Hospital, Sichuan University, Sichuan, China
Xiao Wen Li. West China Second University Hospital, Sichuan University, Sichuan, China
Yan Ling Hu. West China Second University Hospital, Sichuan University, Sichuan, China
Xing Li Wan. West China Second University Hospital, Sichuan University, Sichuan, China
Disease Category: Neonatal care
Disease Name: Neonatal care
Age Range: 0 - 1
Sex: Either
Nature of Intervention: Intensive care
- Journal editors
- Methodologists
- Policy makers
- Researchers
- Clinical experts
- Consumers (caregivers)
- COS for clinical trials or clinical research
- COS for practice
- Recommendations for outcome measures (measurement/how)
- Consensus meeting
- Delphi process
- Systematic review
Developing the KMC Core Outcome Set will involve the following six stages: (1) Establishment of a working group, (2) Systematic review, (3) Semi-structured interviews, (4) Initial pool of potential core outcomes, (5) Delphi survey, (6) Consensus meeting.