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Coverage of kangaroo mother care remains very low despite WHO recommendations for its use for babies with low birthweight in health facilities for over a decade. Initiating kangaroo mother care at the community level is a promising strategy to increase coverage. However, knowledge of the efficacy of community-initiated kangaroo mother care is still lacking. We aimed to assess the effect of community-initiated kangaroo mother care provided to babies weighing 1500–2250 g on neonatal and infant survival. In this randomised controlled, superiority trial, undertaken in Haryana, India, we enrolled babies weighing 1500–2250 g at home within 72 h of birth, if not already initiated in kangaroo mother care, irrespective of place of birth (ie, home or health facility) and who were stable and feeding. The first eligible infants in households were randomly assigned (1:1) to the intervention (community-initiated kangaroo mother care) or control group by block randomisation using permuted blocks of variable size. Twins were allocated to the same group. For second eligible infants in the same household as an enrolled infant, if the first infant was assigned to the intervention group the second infant was also assigned to this group, whereas if the first infant was assigned to the control group the second infant was randomly assigned (1:1) to the intervention or control group. Mothers and infants in the intervention group were visited at home (days 1–3, 5, 7, 10, 14, 21, and 28) to support kangaroo mother care (ie, skin-to-skin contact and exclusive breastfeeding). The control group received routine care. The two primary outcomes were mortality between enrolment and 28 days and between enrolment and 180 days. Analysis was by intention to treat and adjusted for clustering within households. The effect of the intervention on mortality was assessed with person-time in the denominator using Cox proportional hazards model. This study is registered with ClinicalTrials.gov, NCT02653534 and NCT02631343, and is now closed to new participants. Between July 30, 2015, and Oct 31, 2018, 8402 babies were enrolled, of whom 4480 were assigned to the intervention group and 3922 to the control group. Most births (6837 [81·4%]) occurred at a health facility, 36·2% (n=3045) had initiated breastfeeding within 1 h of birth, and infants were enrolled at an average of about 30 h (SD 17) of age. Vital status was known for 4470 infants in the intervention group and 3914 in the control group at age 28 days, and for 3653 in the intervention group and 3331 in the control group at age 180 days. Between enrolment and 28 days, 73 infants died in 4423 periods of 28 days in the intervention group and 90 deaths in 3859 periods of 28 days in the control group (hazard ratio [HR] 0·70, 95% CI 0·51–0·96; p=0·027). Between enrolment and 180 days, 158 infants died in 3965 periods of 180 days in the intervention group and 184 infants died in 3514 periods of 180 days in the control group (HR 0·75, 0·60–0·93; p=0·010). The risk ratios for death were almost the same as the HRs (28-day mortality 0·71, 95% CI 0·52– 0·97; p=0·032; 180-day mortality 0·76, 0·60–0·95; p=0·017). Community-initiated kangaroo mother care substantially improves newborn baby and infant survival. In low-income and middle-income countries, incorporation of kangaroo mother care for all infants with low birthweight, irrespective of place of birth, could substantially reduce neonatal and infant mortality. Research Council of Norway and University of Bergen.

Although kangaroo mother care (KMC) has been shown to be safe and effective in randomized controlled trials (RCTs), there are no published complete economic evaluations including the three components of the full intervention. A cost utility analysis performed on the results of an RCT conducted in Bogotá, Colombia between 1993 and 1996. Hospital and ambulatory costs were estimated by microcosting in a sample of preterm infants from a University Hospital in Bogotá in 2011 and at a KMC clinic in the same period. Utility scores were assigned by experts by means of (1) direct ordering and scoring discrete health states and (2) constructing a multi-attribute utility function. Ninety-five percent confidence intervals (CIs) for the incremental cost–utility ratios (ICURs) were computed by the Fiellers theorem method. One-way sensitivity analysis on price estimates for valuing costs was performed. ICUR at 1 year of corrected age was $ −1,546 per extra quality-adjusted life year gained using the KMC method (95% CI $ −7,963 to $ 4,910). In Bogotá, the use of KMC is dominant: more effective and cost-saving. Although results from an economic analysis should not be extrapolated to different systems and communities, this dominant result suggests that KMC could be cost-effective in similar low and middle income countries settings.

ObjectivesThe objectives are to assess the effectiveness of a modified and adapted oral sensorimotor intervention (MA-OSMI) protocol for infants in India on the rate and performance of breastfeeding among preterm (PT) infants at discharge.DesignSingle-centre randomised control trial.SettingLevel III B neonatal intensive care unit in a quaternary care hospital in South India.PatientsA total of 76 PT infants born between 26 and 33+6 weeks of gestational age, stratified into <30 weeks and 30–33+6 weeks, were randomised to intervention group (MA-OSMI) or standard care (SC).InterventionsMA-OSMI in addition to SC versus SC alone. The stimulation included 12 techniques administered by the principal investigator. SC included kangaroo mother care and non-nutritive sucking.Outcome measuresExclusive breastfeeding (EBF) rate and breastfeeding performance at the time of discharge, assessed using standardised tools by clinician and mothers.ResultsInfants in MA-OSMI group (66%) had significantly higher EBF rate compared with the SC group (16%) (OR: 10.25; 95% CI: 3.41 to 30.80). Improved breastfeeding performance was noted as per the clinician’s observation. Significantly lower scores for MA-OSMI groups (63.42±36.43) than SC groups (126.61±60.94) on mothers’ ratings suggested better feeding skills.ConclusionPrefeeding oral stimulation contributed significantly to the achievement of EBF among PT infants at discharge. The present findings may benefit speech–language pathologists, paediatricians/neonatologists and nurses in the intervention of oral feeding among neonates.

Background Preterm birth complications result in > 1 million child deaths annually, mostly in low- and middle-income countries. A World Health Organisation (WHO)-led trial in hospitals with intensive care reported reduced mortality within 28 days among newborns weighing 1000–1799 g who received immediate kangaroo mother care (iKMC) compared to those who received standard care. Evidence is needed regarding the process and costs of implementing iKMC, particularly in non-intensive care settings. Methods We describe actions undertaken to implement iKMC, estimate financial and economic costs of essential resources and infrastructure improvements, and assess readiness for newborn care after these improvements at five Ugandan hospitals participating in the OMWaNA trial. We estimated costs from a health service provider perspective and explored cost drivers and cost variation across hospitals. We assessed readiness to deliver small and sick newborn care (WHO level-2) using a tool developed by Newborn Essential Solutions and Technologies and the United Nations Children’s Fund. Results Following the addition of space to accommodate beds for iKMC, floor space in the neonatal units ranged from 58 m 2 to 212 m 2 . Costs of improvements were lowest at the national referral hospital (financial: $31,354; economic: $45,051; 2020 USD) and varied across the four smaller hospitals (financial: $68,330-$95,796; economic: $99,430-$113,881). In a standardised 20-bed neonatal unit offering a level of care comparable to the four smaller hospitals, the total financial cost could be in the range of $70,000 to $80,000 if an existing space could be repurposed or remodelled, or $95,000 if a new unit needed to be constructed. Even after improvements, the facility assessments demonstrated broad variability in laboratory and pharmacy capacity as well as the availability of essential equipment and supplies. Conclusions These five Ugandan hospitals required substantial resource inputs to allow safe implementation of iKMC. Before widespread scale-up of iKMC, the affordability and efficiency of this investment must be assessed, considering variation in costs across hospitals and levels of care. These findings should help inform planning and budgeting as well as decisions about if, where, and how to implement iKMC, particularly in settings where space, devices, and specialised staff for newborn care are unavailable. Trial registration ClinicalTrials.gov, NCT02811432 . Registered: 23 June 2016.

Background Kangaroo mother care (KMC) is recommended as a beneficial intervention to promote the wellbeing of preterm infants. This study evaluated the effect of KMC on anthropometric indexes in preterm newborns, with and without telephone advice (TA). Methods At a tertiary center, in a single-blinded, randomized controlled trial (RCT), one hundred and five discharged preterm infants from the neonatal intensive care unit (NICU) were randomly allocated into two experimental groups: KMC, KMC with telephone advice (KMC-TA), and conventional care (CC) (35 birthing parent-infant pairs in each group). In two experimental groups, a research assistant trained participants on how to do KMC at home for a maximum of three times, at least 3–4 h daily, during a one-month period. In the KMC-TA group, participants were counseled on KMC by phone, twice a week. In CC group, routine care was provided. Prior to, and at the end of the intervention, anthropometric indexes including the weight, height, head and chest circumferences of neonates were measured in the three groups. The ANOVA, Kruskal–Wallis, Chi-square, Fisher’s exact test, and Bonferroni was used to analyse the data. Results After one month, the mean weight of neonates was significantly greater in the two experimental groups when compared to those the CC group ( p  = 0.006). No significant differences were observed in other anthropometric indexes. Conclusions Short–term implementation of KMC has a positive effect on preterm infant weight gain. Optimal implementation strategies for KMC are required, and future research may usefully inform these. Trial registration This trial was registered in the Iranian Registry of Clinical Trials with code IRCT201306082324N11 on 28/4/2014. URL of registry https://irct.behdasht.gov.ir/trial/1966 . Highlights Kangaroo mother care is currently considered one of the most cost-effective interventions promoting the wellbeing of preterm infants. Short–term implementation of KMC has a positive effect on preterm infant weight gain. It did not affect other anthropometric measurements.

This randomized controlled trial evaluated the effect of a 5‐week daily skin‐to‐skin contact (SSC) intervention between mothers and their full‐term infants, compared with care‐as‐usual, on exclusive and continued breastfeeding duration during the first post‐natal year. Healthy pregnant women (n = 116) from a community sample were enrolled and randomly allocated to the SSC or care‐as‐usual condition. SSC mothers were requested to provide one daily hour of SSC for the first five post‐natal weeks. Twelve months post‐partum, mothers indicated the number of exclusive and continued breastfeeding months. Multiple regression analyses were conducted using intention‐to‐treat, per‐protocol and exploratory dose–response frameworks. In intention‐to‐treat analyses, exclusive and continued breastfeeding duration was not different between groups (exclusive: 3.61 ± 1.99 vs. 3.16 ± 1.77 months; adjusted mean difference 0.28, 95% confidence interval [CI] −0.33 to 0.89; p = 0.36; continued: 7.98 ± 4.20 vs. 6.75 ± 4.06 months; adjusted mean difference 0.81, 95% CI −0.46 to 2.08; p = 0.21). In per‐protocol analyses, exclusive and continued breastfeeding duration was longer for SSC than care‐as‐usual dyads (exclusive: 4.89 ± 1.26 vs. 3.25 ± 1.80 months; adjusted mean difference 1.28, 95% CI 0.31–2.24; p = 0.01; continued: 10.81 ± 1.97 vs. 6.98 ± 4.08 months; adjusted mean difference 2.33, 95% CI 0.13–4.54; p = 0.04). Exploratory dose–response effects indicated that more SSC hours predicted longer exclusive and continued breastfeeding duration. This study demonstrates that for the total group, the 5‐week daily SSC intervention did not extend exclusive and continued breastfeeding duration. However, for mothers performing a regular daily hour of SSC, this simple and accessible intervention may extend exclusive and continued breastfeeding duration by months. Future studies are required to confirm these promising findings. Trial registration: Netherlands Trial Register (NTR5697).

Kangaroo mother care (KMC) reduces mortality and morbidity in newborns, particularly benefiting preterm infants. However, substantial heterogeneity in the selection, measurement, and reporting of outcomes across KMC trials hinders evidence synthesis and clinical application, underscoring the urgent need for standardized core outcomes. To identify outcomes used to evaluate KMC as the foundational step toward developing a core outcome set. We followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement for reporting. A comprehensive search of MEDLINE, Cochrane Library, Embase, CINAHL, CNKI, SinoMed, WanFang Data, and clinical trial registries was conducted for studies published or registered from January 1, 2014 to July 7, 2024. Risk of bias in the studies was not assessed, as the review did not focus on efficacy. Data on literature and outcomes were extracted for narrative synthesis. Outcomes were categorized using the COMET outcome taxonomy. A total of 5730 studies were screened, and 292 studies were included in this review, consisting of 162 articles and 130 protocols, with a total of 112,601 participants. These studies were conducted across 40 countries, with the majority from lower-middle-income countries and upper-middle-income countries. A total of 1306 outcomes were extracted, resulting in 142 unique outcomes, which spanned 5 core areas and 29 outcome domains. The most frequently reported core area was physiological/clinical (256 studies, 87.67%), followed by the life impact (116 studies, 39.73%). In contrast, the death core area received limited attention, with only 10.96% of studies reporting mortality or survival outcomes. The most commonly reported outcome domain was general outcomes (185 studies, 63.36%), followed by pregnancy, puerperium, and perinatal outcomes (84 studies, 28.77%). The three most reported outcomes were breastfeeding outcomes (84 studies, 28.77%), weight/length/head circumference/(82 studies, 28.08%), and pain (67 studies, 22.95%). Current research on outcome reporting for KMC is comprehensive, covering most outcome domain across the five core areas. However, significant heterogeneity in outcome definitions and reporting exists across studies. Therefore, the development of a core outcome set for KMC is critical to reduce this heterogeneity, facilitate comparisons between studies, and enhance the integration of results into clinical practice and future research.

Background Premature newborns admitted to neonatal intensive care units (NICUs) undergo numerous painful interventions during care and treatment. The purpose of this study was to compare the effects of using sucrose and kangaroo mother care by on selected physiological variables and pain resulting from venipuncture in premature infants admitted to NICUs affiliated with Shiraz University of Medical Sciences. Methods This clinical trial included premature infants admitted to 2 NICUs. The sample size consisted of 66 neonates, with 22 newborns in each group. Randomization was performed using the block allocation method. Data collection involved a demographic questionnaire, the neonatal infant pain scale, and a pulse oximetry device. Friedman, Kruskal–Wallis, and Dunn’s post hoc tests employed for data analysis, with a significance level of P  < 0.05. Results The use of oral sucrose and kangaroo care demonstrated significant differences in breathing rate, heart rate, and average arterial blood oxygen saturation during and after venipuncture ( P  < 0.05). Oral sucrose was found to be significantly more effective than kangaroo care. Neonates under kangaroo care exhibited more regular heart rates compared to the other group ( P  < 0.05). The utilization of oral sucrose and kangaroo care had varying effects on the average pain score resulting from venipuncture in premature neonates ( P  < 0.05). Conclusions Both methods proved effective in reducing pain and improving physiological variables. However, due to the superior effectiveness of sucrose administration, it is recommended as a cost-effective and easily implementable method in NICUs. Trial registration : Iranian Registry of Clinical Trials IRCT20191215045749N1. (29/03/2020).

IntroductionMother-infant skin-to-skin contact (SSC) improves developmental and cognitive outcomes in preterm infants. However, the effects of SSC on healthy term infants remain unclear. We aim to investigate the short-term and long-term impacts of SSC in full-term infants to provide supporting data emphasising the importance of mother-infant SSC in South Korea.Methods and analysisThis study is a prospective, double-blind, randomised controlled trial. A total of 130 mothers and their healthy term infants will be recruited after birth. Participants will be randomised to the intervention (SSC) or control groups. Participants in both groups will be instructed on general newborn care guidance and requested to record the same in a mobile diary app daily for 2 weeks after hospital discharge. The intervention group will be educated on the importance and clinical advantages of mother-infant SSC and provided with practical guidance, along with an informational pamphlet. They will also be informed to engage in a minimum of 6 hours of SSC per day with the infant’s and mother’s chests exposed and in contact for at least 15 min per session and to keep a record of the contact time. Breastfeeding rate, time spent on SSC and holding clothed infant, maternal depression, anxiety and bonding scores will be measured. Infants’ growth, temperament and neurodevelopmental outcomes will be assessed. In addition, artificial intelligence algorithms will be developed to analyse infant movements captured in videos.Ethics and disseminationThis study was approved by the institutional review board of the Korea University Anam Hospital (2024AN0613), and the results will be disseminated through scientific conferences and publications.Trial registration numberNCT06777524, registered on 14 January 2025.

Background Kangaroo mother care (KMC) can have a positive effect on the mental well-being of a mother. However, there are specific challenges associated with the process that may contribute to increased anxiety for the mother. By integrating nurse-assisted mindfulness training alongside KMC guidance, nurses may effectively alleviate maternal stress to a greater extent. Methods A single-centre randomized controlled trial was conducted to investigate the effects of KMC combined with nurse-assisted mindfulness training. The study included preterm infants with a gestational age of less than 32 weeks or a birth weight of less than 1500 g and their mothers, who were randomly divided into two groups. The intervention group consisted of mothers who received KMC combined with nurse-assisted mindfulness training for 14 days. The control group comprised mothers who received only KMC for 14 days. Data from both groups were collected and compared for analysis. Results Forty-seven infants and their mothers were included in the intervention group, whereas 44 pairs were included in the control group. After the intervention, the parental stressor scale scores for the neonatal intensive care unit (PSS: NICU) (3), PSS: NICU (4), and Hospital Anxiety and Depression Scale (HADS) scores for the intervention group were lower than those for the control group, whereas the Five Facet Mindfulness Questionnaire (FFMQ) (1), FFMQ (4), and FFMQ (5) scores for the intervention group were higher. The degree of change in the PSS: NICU and HADS scores was inversely correlated with the degree of change in the FFMQ score. The breast milk feed rate and weight gain rate were greater in the intervention group than in the control group. No adverse reactions were observed in either group. Conclusions Kangaroo mother care combined with nurse-assisted mindfulness training is an acceptable, feasible, and effective procedure for reducing anxiety in mothers of preterm infants in the NICU, with potential benefits for the short-term prognosis of these infants. Trial registration Chinese Clinical Trial Registry, ChiCTR1900023697, registered on June 8, 2019, retrospectively registered.