Dataset Information

Protocol for a randomised trial of early kangaroo mother care compared to standard care on survival of pre-stabilised preterm neonates in The Gambia (eKMC).

ABSTRACT: BACKGROUND:Complications of preterm birth cause more than 1 million deaths each year, mostly within the first day after birth (47%) and before full post-natal stabilisation. Kangaroo mother care (KMC), provided as continuous skin-to-skin contact for 18?h per day to fully stabilised neonates ? 2000?g, reduces mortality by 36-51% at discharge or term-corrected age compared with incubator care. The mortality effect of starting continuous KMC before stabilisation is a priority evidence gap, which we aim to investigate in the eKMC trial, with a secondary aim of understanding mechanisms, particularly for infection prevention. METHODS:We will conduct a single-site, non-blinded, individually randomised, controlled trial comparing two parallel groups to either early (within 24?h of admission) continuous KMC or standard care on incubator or radiant heater with KMC when clinically stable at >?24?h of admission. Eligible neonates (n =?392) are hospitalised singletons or twins

SUBMITTER: Brotherton H

PROVIDER: S-EPMC7059319 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Protocol for a randomised trial of early kangaroo mother care compared to standard care on survival of pre-stabilised preterm neonates in The Gambia (eKMC).

Brotherton Helen H Gai Abdou A Tann Cally J CJ Samateh Ahmadou Lamin AL Seale Anna C AC Zaman Syed M A SMA Cousens Simon S Roca Anna A Lawn Joy E JE

Trials 20200306 1

<h4>Background</h4>Complications of preterm birth cause more than 1 million deaths each year, mostly within the first day after birth (47%) and before full post-natal stabilisation. Kangaroo mother care (KMC), provided as continuous skin-to-skin contact for 18 h per day to fully stabilised neonates ≤ 2000 g, reduces mortality by 36-51% at discharge or term-corrected age compared with incubator care. The mortality effect of starting continuous KMC before stabilisation is a priority evidence gap, ...[more]

PMID: 32143737

Similar Datasets

Project description:BackgroundUnderstanding the effect of early kangaroo mother care on survival of mild-moderately unstable neonates <2000 g is a high-priority evidence gap for small and sick newborn care.MethodsThis non-blinded pragmatic randomised clinical trial was conducted at the only teaching hospital in The Gambia. Eligibility criteria included weight <2000g and age 1-24 h with exclusion if stable or severely unstable. Neonates were randomly assigned to receive either standard care, including KMC once stable at >24 h after admission (control) versus KMC initiated <24 h after admission (intervention). Randomisation was stratified by weight with twins in the same arm. The primary outcome was all-cause mortality at 28 postnatal days, assessed by intention to treat analysis. Secondary outcomes included: time to death; hypothermia and stability at 24 h; breastfeeding at discharge; infections; weight gain at 28d and admission duration. The trial was prospectively registered at www.clinicaltrials.gov (NCT03555981).FindingsRecruitment occurred from 23rd May 2018 to 19th March 2020. Among 1,107 neonates screened for participation 279 were randomly assigned, 139 (42% male [n = 59]) to standard care and 138 (43% male [n = 59]) to the intervention with two participants lost to follow up and no withdrawals. The proportion dying within 28d was 24% (34/139, control) vs. 21% (29/138, intervention) (risk ratio 0·84, 95% CI 0·55 - 1·29, p = 0·423). There were no between-arm differences for secondary outcomes or serious adverse events (28/139 (20%) for control and 30/139 (22%) for intervention, none related). One-third of intervention neonates reverted to standard care for clinical reasons.InterpretationThe trial had low power due to halving of baseline neonatal mortality, highlighting the importance of implementing existing small and sick newborn care interventions. Further mortality effect and safety data are needed from varying low and middle-income neonatal unit contexts before changing global guidelines.

Project description:Despite introduction of Kangaroo Mother Care (KMC) in Malawi over a decade ago, preterm birth remains the leading cause of neonatal mortality. Although KMC is initiated in the health care facility, robust community follow-up is critical for survival and optimal development of preterm and low birth weight infants post-discharge. The objective of this qualitative study was to gain insight into community and health worker understanding, attitudes, beliefs and practices around preterm and low birth weight babies and KMC in Malawi.A total of 152 participants were interviewed in two districts in southern Malawi, Machinga and Thyolo, in April 2015. Focus group discussions (groups = 11, n = 132) were conducted with pregnant women, community members and women who have practiced KMC. In-depth interviews (n = 20) were conducted with fathers who have practiced KMC, community and religious leaders, and health workers. Purposive and snowball sampling were employed to identify participants. Thematic content analysis was conducted.KMC mothers and fathers only learned about KMC and care for preterm newborns after delivery of a child in need of this care. Men typically were not included in KMC counseling due to societal gender roles. Health facilities were the main source of information on KMC, however informal networks among women provided some degree of knowledge exchange. Community leaders were regarded as major facilitators of health information, conveners, key influencers, and policy-makers. Religious leaders were regarded as advocates and emotional support for families with preterm infants. Finally, while many participants initially had negative feelings towards preterm births and KMC, the large majority saw a shift in their perceptions through health counseling, peer modeling, and personal success with KMC.The findings offer several opportunities to improve KMC implementation including 1) earlier introduction of KMC to pregnant women and their families that are at-risk for preterm birth, 2) greater involvement of men in KMC counselling, practice and care for preterm infants, and 3) strengthening and defining partnerships with community and religious leaders. Finally, as parental perceptions of preterm infants and KMC improved with successful KMC practice, it is hopeful that KMC itself can positively affect social norms surrounding preterm infants, leading to a virtuous cycle of improved perceptions of preterm infants and increased uptake of KMC.

Project description:BackgroundKangaroo mother care (KMC) reduces mortality among stable neonates ≤2000 g. Lack of data tracking coverage and quality of KMC in both surveys and routine information systems impedes scale-up. This paper evaluates KMC measurement as part of the Every Newborn Birth Indicators Research Tracking in Hospitals (EN-BIRTH) study.MethodsThe EN-BIRTH observational mixed-methods study was conducted in five hospitals in Bangladesh, Nepal and Tanzania from 2017 to 2018. Clinical observers collected time-stamped data as gold standard for mother-baby pairs in KMC wards/corners. To assess accuracy, we compared routine register-recorded and women's exit survey-reported coverage to observed data, using different recommended denominator options (≤2000 g and ≤ 2499 g). We analysed gaps in quality of provision and experience of KMC. In the Tanzanian hospitals, we assessed daily skin-to-skin duration/dose and feeding frequency. Qualitative data were collected from health workers and data collectors regarding barriers and enablers to routine register design, filling and use.ResultsAmong 840 mother-baby pairs, compared to observed 100% coverage, both exit-survey reported (99.9%) and register-recorded coverage (92.9%) were highly valid measures with high sensitivity. KMC specific registers outperformed general registers. Enablers to register recording included perceptions of data usefulness, while barriers included duplication of data elements and overburdened health workers. Gaps in KMC quality were identified for position components including wearing a hat. In Temeke Tanzania, 10.6% of babies received daily KMC skin-to-skin duration/dose of ≥20 h and a further 75.3% received 12-19 h. Regular feeding ≥8 times/day was observed for 36.5% babies in Temeke Tanzania and 14.6% in Muhimbili Tanzania. Cup-feeding was the predominant assisted feeding method. Family support during admission was variable, grandmothers co-provided KMC more often in Bangladesh. No facility arrangements for other family members were reported by 45% of women at exit survey.ConclusionsRoutine hospital KMC register data have potential to track coverage from hospital KMC wards/corners. Women accurately reported KMC at exit survey and evaluation for population-based surveys could be considered. Measurement of content, quality and experience of KMC need consensus on definitions. Prioritising further KMC measurement research is important so that high quality data can be used to accelerate scale-up of high impact care for the most vulnerable.

Project description:Skin-to-skin contact (SSC) between mother and infant, commonly referred to as Kangaroo Mother Care (KMC), is recommended as an intervention for procedural pain. Evidence demonstrates its consistent efficacy in reducing pain for a single painful procedure. The purpose of this study is to examine the sustained efficacy of KMC, provided during all routine painful procedures for the duration of Neonatal Intensive Care Unit (NICU) hospitalization, in diminishing behavioral pain response in preterm neonates. The efficacy of KMC alone will be compared to standard care of 24% oral sucrose, as well as the combination of KMC and 24% oral sucrose.Infants admitted to the NICU who are less than 36 6/7 weeks gestational age (according to early ultrasound), that are stable enough to be held in KMC, will be considered eligible (N?=?258). Using a single-blinded randomized parallel group design, participants will be assigned to one of three possible interventions: 1) KMC, 2) combined KMC and sucrose, and 3) sucrose alone, when they undergo any routine painful procedure (heel lance, venipuncture, intravenous, oro/nasogastric insertion). The primary outcome is infant's pain intensity, which will be assessed using the Premature Infant Pain Profile (PIPP). The secondary outcome will be maturity of neurobehavioral functioning, as measured by the Neurobehavioral Assessment of the Preterm Infant (NAPI). Gestational age, cumulative exposure to KMC provided during non-pain contexts, and maternal cortisol levels will be considered in the analysis. Clinical feasibility will be accounted for from nurse and maternal questionnaires.This will be the first study to examine the repeated use of KMC for managing procedural pain in preterm neonates. It is also the first to compare KMC to sucrose, or the interventions in combination, across time. Based on the theoretical framework of the brain opioid theory of attachment, it is expected that KMC will be a preferred standard of care. However, current pain management guidelines are based on minimal data on repeated use of either intervention. Therefore, regardless of the outcomes of this study, results will have important implications for guidelines and practices related to management of procedural pain in preterm infants.ClinicalTrials.gov Identifier: NCT01561547.

Project description:Kangaroo mother care (KMC) is an evidence-based approach to reducing mortality and morbidity in preterm infants. Although KMC is a key intervention package in newborn health initiatives, there is limited systematic information available on the barriers to KMC practice that mothers and other stakeholders face while practicing KMC. This systematic review sought to identify the most frequently reported barriers to KMC practice for mothers, fathers, and health practitioners, as well as the most frequently reported enablers to practice for mothers. We searched nine electronic databases and relevant reference lists for publications reporting barriers or enablers to KMC practice. We identified 1,264 unique publications, of which 103 were included based on pre-specified criteria. Publications were scanned for all barriers / enablers. Each publication was also categorized based on its approach to identification of barriers / enablers, and more weight was assigned to publications which had systematically sought to understand factors influencing KMC practice. Four of the top five ranked barriers to KMC practice for mothers were resource-related: "Issues with the facility environment / resources," "negative impressions of staff attitudes or interactions with staff," "lack of help with KMC practice or other obligations," and "low awareness of KMC / infant health." Considering only publications from low- and middle-income countries, "pain / fatigue" was ranked higher than when considering all publications. Top enablers to practice were included "mother-infant attachment" and "support from family, friends, and other mentors." Our findings suggest that mother can understand and enjoy KMC, and it has benefits for mothers, infants, and families. However, continuous KMC may be physically and emotionally difficult, and often requires support from family members, health practitioners, or other mothers. These findings can serve as a starting point for researchers and program implementers looking to improve KMC programs.

Project description:ObjectiveTo describe how mothers of late preterm infants experienced the provision of intermittent kangaroo mother care (KMC) in four postnatal wards in different hospitals in China, under a pilot KMC project.DesignA concurrent mixed-methods approach incorporating quantitative maternal questionnaires and qualitative semistructured interviews.SettingFour postnatal wards in level-III hospitals based in different provinces of Southeast and Northwest China.ParticipantsAll 752 mothers who provided intermittent KMC to their late preterm newborns in the four participating postnatal wards consented to participate in the study (quantitative component), as well as six nurses, two obstetricians and two mothers from two of the participating postnatal wards (qualitative component).Outcome measuresMaternal KMC experiences during a hospital stay, patients' perceptions of KMC initiation, processes, benefits and challenges.ResultsMost mothers had not heard of KMC before being introduced to it in the postnatal ward. On average, mothers and newborns stayed in postnatal wards for 3.6 days; during their stay, mothers provided an average of 3.5 KMC sessions, which is an average of 1.1 sessions a day. Each KMC session lasted an average of 68 min, though there was much variation in the length of a session. Common reasons given for discontinuing a KMC session included restroom use, infant crying and perceived time limitations. Some mothers would have preferred to provide KMC for longer periods of time and nurses encouraged this. Most mothers experienced no difficulty providing KMC, received support from family and medical staff and intended to continue with KMC postdischarge.ConclusionIn order to improve the maternal experience of KMC, it is recommended that raising awareness of KMC should be included in antenatal care and after birth. Longer periods of KMC provision should be encouraged, greater privacy should be provided for mothers providing KMC in postnatal wards and family members should be encouraged to support KMC.

Project description:BackgroundKangaroo mother care (KMC) is an evidence-based intervention with large protective effects on neonatal mortality and morbidity, especially among small babies. Despite the available evidence, KMC adoption, implementation and scale-up has lagged. The purpose of this paper is to inform current and future KMC implementation by identifying achievements and challenges in countries that are in the process of scaling up KMC.MethodsWe collected and analyzed information to track the status of facility-based KMC in countries identified by the KMC Acceleration Partnership. We assessed the status of the scale-up in six priority countries (Ethiopia, Malawi, Nigeria and Rwanda in Africa, and Bangladesh and India in Asia) for three periods: 2014 and prior, 2015-2017 and 2017-2019 across six strategic areas: national policy, country implementation, research, knowledge management, monitoring and evaluation and advocacy. We collected information through in-depth interviews with key participants, quantitative data extraction from the Demographic Health Survey and secondary data extraction from policies, briefs, program reports and other documents.ResultsProgress in terms of national policy and advocacy appeared to occur quite quickly and evenly across the six priority countries, despite being at different stages during the first assessment. In the areas of country implementation support and research, progress occurred more slowly and results were more variable across countries. It was noted that the number of health facilities offering KMC services increased in all six priority countries, but coverage of KMC was difficult to estimate, demonstrating the ongoing challenges in the area of monitoring and evaluation despite progress made in integrating KMC indicators into national health information systems in five countries. Among the six priority countries - Malawi and Bangladesh had fully achieved at least four the first time six conditions were introduced.ConclusionsWe documented notable achievements in the dimensions of policy and country implementation across the six countries, which were likely driven by government engagement to prioritize newborn care services and the promotion of KMC as a core intervention for small babies. We noted challenges in critical areas such as ambulatory KMC, follow-up, and monitoring and evaluation. Addressing these gaps while securing funding to allocate human resources adequately, promoting acceptance of KMC for demand creation and facilitating the use of data for decision making will be vital to ensure effective coverage at scale.

Dataset Information

Protocol for a randomised trial of early kangaroo mother care compared to standard care on survival of pre-stabilised preterm neonates in The Gambia (eKMC).

Publications

Protocol for a randomised trial of early kangaroo mother care compared to standard care on survival of pre-stabilised preterm neonates in The Gambia (eKMC).

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets