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Is a woolen cap effective in maintaining normothermia in low-birth-weight infants during kangaroo mother care? Study protocol for a randomized controlled trial.

ABSTRACT: Neonatal hypothermia is an important challenge associated with morbidity and mortality. Preventing neonatal hypothermia is important in high-resource countries, but is of fundamental importance in low-resource settings where supportive care is limited. Kangaroo mother care (KMC) is a low-cost intervention that, whenever possible, is strongly recommended for temperature maintenance. During KMC, the World Health Organization (WHO) guidelines recommend the use of a cap/hat, but its effect on temperature control during KMC remains to be established. In the hospitals participating in the projects of the non-governmental organization CUAMM, KMC represents a standard of care, but the heads of the babies often remain uncovered due to local habits or to the unavailability of a cap. The aim of the present study will be to assess the effectiveness and safety of using a woolen cap in maintaining normothermia in low-birth-weight infants (LBWI) during KMC.This is a multicenter (three hospitals), multicountry (three countries), prospective, unblinded, randomized controlled trial of KMC treatment with and without a woolen cap in LBWI. After obtaining parental consent, all infants with a birth weight below 2500 g and who are candidates for KMC, based on the clinical decision of the attending physician, will be assigned to the KMC with a woolen cap group or to the KMC without a woolen cap group in a 1:1 ratio according to a computer-generated, randomized sequence. The duration of the study will be until the patient's discharge, with a maximum treatment duration of 7 days. The primary outcome measure will be whether the infants' temperatures remain within the normal range (36.5-37.5 °C) in the course of KMC during the intervention. In all participants, axillary temperature will be measured with a digital thermometer four times per day. In addition, maternal and room temperature will be recorded. Secondary outcome measures will be: episodes of apnea; sepsis; mortality before hospital discharge; in-hospital growth; and age at discharge.The findings of this study will be important for other units/settings in high- as well low-resource countries where KMC is routinely performed. Based on the results of the present study, we could speculate whether the use of a woolen cap may help to maintain the neonate within the normal thermal range. Furthermore, potential complications such as hyperthermia will be strictly monitored and collected.ClinicalTrials.gov Identifier: NCT02645526 (registered on 31 December 2015).

SUBMITTER: Trevisanuto D

PROVIDER: S-EPMC4882808 | biostudies-literature | 2016 May

REPOSITORIES: biostudies-literature

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Is a woolen cap effective in maintaining normothermia in low-birth-weight infants during kangaroo mother care? Study protocol for a randomized controlled trial.

Trevisanuto Daniele D Putoto Giovanni G Pizzol Damiano D Serena Tiziana T Manenti Fabio F Varano Silvia S Urso Eleonora E Massavon William W Tsegaye Ademe A Wingi Oliver O Onapa Emanuel E Segafredo Giulia G Cavallin Francesco F

Trials 20160526 1

<h4>Background</h4>Neonatal hypothermia is an important challenge associated with morbidity and mortality. Preventing neonatal hypothermia is important in high-resource countries, but is of fundamental importance in low-resource settings where supportive care is limited. Kangaroo mother care (KMC) is a low-cost intervention that, whenever possible, is strongly recommended for temperature maintenance. During KMC, the World Health Organization (WHO) guidelines recommend the use of a cap/hat, but i ...[more]

PMID: 27229315

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Project description:Background"Kangaroo mother care," a type of newborn care involving skin-to-skin contact with the mother or other caregiver, reduces mortality in infants with low birth weight (<2.0 kg) when initiated after stabilization, but the majority of deaths occur before stabilization. The safety and efficacy of kangaroo mother care initiated soon after birth among infants with low birth weight are uncertain.MethodsWe conducted a randomized, controlled trial in five hospitals in Ghana, India, Malawi, Nigeria, and Tanzania involving infants with a birth weight between 1.0 and 1.799 kg who were assigned to receive immediate kangaroo mother care (intervention) or conventional care in an incubator or a radiant warmer until their condition stabilized and kangaroo mother care thereafter (control). The primary outcomes were death in the neonatal period (the first 28 days of life) and in the first 72 hours of life.ResultsA total of 3211 infants and their mothers were randomly assigned to the intervention group (1609 infants with their mothers) or the control group (1602 infants with their mothers). The median daily duration of skin-to-skin contact in the neonatal intensive care unit was 16.9 hours (interquartile range, 13.0 to 19.7) in the intervention group and 1.5 hours (interquartile range, 0.3 to 3.3) in the control group. Neonatal death occurred in the first 28 days in 191 infants in the intervention group (12.0%) and in 249 infants in the control group (15.7%) (relative risk of death, 0.75; 95% confidence interval [CI], 0.64 to 0.89; P = 0.001); neonatal death in the first 72 hours of life occurred in 74 infants in the intervention group (4.6%) and in 92 infants in the control group (5.8%) (relative risk of death, 0.77; 95% CI, 0.58 to 1.04; P = 0.09). The trial was stopped early on the recommendation of the data and safety monitoring board owing to the finding of reduced mortality among infants receiving immediate kangaroo mother care.ConclusionsAmong infants with a birth weight between 1.0 and 1.799 kg, those who received immediate kangaroo mother care had lower mortality at 28 days than those who received conventional care with kangaroo mother care initiated after stabilization; the between-group difference favoring immediate kangaroo mother care at 72 hours was not significant. (Funded by the Bill and Melinda Gates Foundation; Australian New Zealand Clinical Trials Registry number, ACTRN12618001880235; Clinical Trials Registry-India number, CTRI/2018/08/015369.).

Project description:Around 70% neonatal deaths occur in low birth weight (LBW) babies. Globally, 15% of babies are born with LBW. Kangaroo Mother Care (KMC) appears to be an effective way to reduce mortality and morbidity among LBW babies. KMC comprises of early and continuous skin-to-skin contact between mother and baby as well as exclusive breastfeeding. Evidence derived from hospital-based studies shows that KMC results in a 40% relative reduction in mortality, a 58% relative reduction in the risk of nosocomial infections or sepsis, shorter hospital stay, and a lower risk of lower respiratory tract infections in babies with birth weight <2000 g. There has been considerable interest in KMC initiated outside health facilities for LBW babies born at home or discharged early. Currently, there is insufficient evidence to support initiation of KMC in the community (cKMC). Formative research in our study setting, where 24% of babies are born with LBW, demonstrated that KMC is feasible and acceptable when initiated at home for LBW babies. The aim of this trial is to determine the impact of cKMC on the survival of these babies.This randomized controlled trial is being undertaken in the Palwal and Faridabad districts in the State of Haryana, India. Neonates weighing 1500-2250 g identified within 3 days of birth and their mothers are being enrolled. Other inclusion criteria are that the family is likely to be available in the study area over the next 6 months, that KMC was not initiated in the delivery facility, and that the infant does not have an illness requiring hospitalization. Eligible neonates are randomized into intervention and control groups. The intervention is delivered through home visits during the first month of life by study workers with a background and education similar to that of workers in the government health system. An independent study team collects mortality and morbidity data as well as anthropometric measurements during periodic home visits. The primary outcomes of the study are postenrollment neonatal mortality and mortality between enrollment and 6 months of age. The secondary outcomes are breastfeeding practices; prevalence of illnesses and care-seeking practices for the same; hospitalizations; weight and length gain; and, in a subsample, neurodevelopment.This efficacy trial will answer the question whether the benefits of KMC observed in hospital settings can also be observed when KMC is started in the community. The formative research used for intervention development suggests that the necessary high level of KMC adoption can be reached in the community, addressing a problem that seriously constrained conclusions in the only other trial in which researchers examined the benefits of cKMC.ClinicalTrials.gov identifier: NCT02653534 . Registered on 26 December 2015 (retrospectively registered).

Project description:BackgroundIn a randomized controlled trial (RCT) with 8402 stable low birthweight (LBW) infants, majority being late preterm or term small for gestational age, community-initiated KMC (ciKMC) showed a significant improvement in survival. However, the effect of ciKMC on neurodevelopment is unclear. This is important to elucidate as children born with low birth weight are at high risk of neurodevelopmental deficits. In the first 552 stable LBW infants enrolled in the above trial, we evaluated the effect of ciKMC on neurodevelopmental outcomes during infancy.MethodThis RCT was conducted among 552 stable LBW infants, majorly late preterm or term small for gestational age infants without any problems at birth and weighing 1500-2250 g at birth. The intervention comprised of promotion of skin-to-skin contact and exclusive breastfeeding by trained intervention delivery team through home visits. The intervention group mother-infant-dyads were supported to practice ciKMC till day 28 after birth or until the baby wriggled-out. All infants in the intervention and control groups received Home Based Post Natal Care (HBPNC) visits by government health workers. Cognitive, language, motor and socio-emotional outcomes were assessed at infant-ages 6- and 12-months using Bayley Scale of Infant Development (BSID-III). Other outcomes measured were infant temperament, maternal depression, maternal sense of competence, mother-infant bonding and home-environment. We performed post-hoc equivalence testing using two one-sided tests of equivalence (TOST) to provide evidence that ciKMC does not do harm in terms of neurodevelopment.ResultsIn the intervention arm, the median (IQR) time to initiate ciKMC was 48 (48 to 72) hours after birth. The mean (SD) duration of skin-to-skin-contact was 27.9 (3.9) days with a mean (SD) of 8.7 (3.5) hours per day. We did not find significant effect of ciKMC on any of the child developmental outcomes during infancy. The TOST analysis demonstrated that composite scores for cognitive, language and motor domains at 12 months among the study arms were statistically equivalent.ConclusionOur study was unable to capture any effect of ciKMC on neurodevelopment during infancy in this sample of stable late preterm or term small for gestational age infants. Long term follow-up may provide meaningful insights.Trial registrationThe trial is registered at clinicaltrials.gov NCT02631343 dated February 17, 2016; Retrospectively registered.

Project description:The Sustainable Development Goal (SDG) 3 emphasises on reducing neonatal deaths caused by low birth weight (LBW) complications by the implementation and utilisation of Kangaroo Mother Care (KMC) in low- and middle-income countries (LMICs). Despite the empirical evidence of KMC optimising low-birth-weight infants' (LBWIs') survival, its advantages and the LMICs implementing the service, studies have shown that LBW infant deaths occurring in LMICs are largely contributing to global child mortality. The aim of this scoping review is to map out the literature on barriers, challenges and facilitators of KMC utilisation by parents with LBWIs.This scoping review will use Endnote X7 reference management software to manage articles. The review search strategy will use SCIELO and LILACS databases. Other databases will be used via EBSCOHost search engine and these are Academic search complete, CINAHL with full text, Education source, Health source: Nursing/Academic Edition, Medline with full text and Medline. We will also use Google Scholar, JSTOR, Open grey search engines and reference lists. A two-phase search mapping out process will be done. In phase 1, one reviewer will perform the title screening and removal of duplicates. Two reviewers will do a parallel abstract screening according to eligibility criteria. Phase 2 will involve the reading of full articles and exclusion of articles, in accordance with the eligibility criteria. Data extraction from the articles will be done by two reviewers independently and parallel to the data extraction form. The data quality assessment of the eligible studies will be done using the Mixed Method Appraisal Tool (MMAT). The extraction of the synthesised results and thematic content analysis of the studies will be done by NVIVO version 10.We expect to find studies on barriers, challenges and facilitating factors of KMC utilisation by parents with LBWIs in LMICs. The review outcomes will guide future research and practice and inform policy. The findings will be disseminated in print, electronic and conference presentations related to maternal child and neonatal health.

Project description:ImportanceApproximately 1 in 5 women in low- and middle-income countries experience postpartum depression, and the risk is higher among mothers of low-birth-weight (LBW) infants. Kangaroo mother care (KMC) is effective in improving survival among LBW infants, but the benefits of KMC for mothers are not well described.ObjectiveTo estimate the effects of community-initiated KMC (ciKMC) on maternal risk of moderate-to-severe postpartum depressive symptoms and on salivary cortisol concentration, a biomarker of stress.Design, setting, and participantsThis was an unmasked, parallel-group, individually randomized clinical trial. Participants included 1950 mothers of stable LBW infants (weighing 1500-2250 g) in rural and semiurban low-income populations in North India enrolled between April 2017 and March 2018. Data analysis was performed from January to July 2020.InterventionsEligible participants were randomly assigned to the intervention or control group by block randomization. The mothers in the intervention group were supported to practice ciKMC until 28 days after birth or until the infant wriggled out of the KMC position (ie, was no longer staying in the KMC position). The intervention included promotion and support of skin-to-skin contact and exclusive breastfeeding through home visits.Main outcomes and measuresPostpartum depressive symptoms at the end of the neonatal period were measured using the Patient Health Questionnaire-9, with a score of 10 or higher used to identify moderate-to-severe depressive symptoms. Salivary cortisol concentration was measured in a subsample of 550 mothers before and after breastfeeding on day 28 after birth.ResultsOf the 1950 participants (mean [SD] age, 23 [3.5] years), outcome assessment was completed for 974 of 1047 participants (93%) in the intervention group and 852 of 903 participants (94%) in the control group. Sixty-four percent of participants (1175 of 1826 participants) belonged to the lowest 3 wealth quintiles. The proportion of mothers with moderate-to-severe postpartum depressive symptoms was 10.8% (95% CI, 8.9%-12.9%; 105 of 974 mothers) in the intervention group vs 13.6% (95% CI, 11.4%-16.1%; 116 of 852 mothers) in the control group. The adjusted relative risk of moderate-to-severe maternal postpartum depressive symptoms was 0.75 (95% CI, 0.59-0.96), or an efficacy of 25%. There was no difference in day-28 salivary cortisol concentration between the ciKMC and control group mothers before or after breastfeeding. The analysis estimated that supporting 36 mothers to perform KMC at home would prevent 1 mother from experiencing moderate-to-severe postpartum depressive symptoms.Conclusions and relevanceThese findings suggest that ciKMC practice may substantially reduce the risk of moderate-to-severe maternal postpartum depressive symptoms. This evidence supports KMC as an intervention to be incorporated in essential newborn care programs in low- and middle-income settings.Trial registrationClinical Trials Registry-India Identifier: CTRI/2017/04/008430.

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:BackgroundKangaroo Mother Care (KMC) is one of the interventions widely used in low-income countries to manage Low Birth Weight Infants (LBWIs), a global leading cause of neonatal and child mortality. LBWI largely contributes to neonatal mortality in Malawi despite the country strengthening and implementing KMC, nationwide, to enhance the survival of LBWIs. This qualitative study aimed to assess the facilitating factors and barriers to accessibility and utilization of KMC service by the parent of low birth weight infants (PLBWIs) in Mangochi District, Malawi.MethodsTwo focused group discussions assessed factors facilitating and hindering the accessibility and utilization of KMC service were conducted in April 2018 that reached out to (N = 12) participants; (n:6) PLBWI practicing KMC at Mangochi district hospital (MDH) referred from four health facilities and (n:6) high-risk pregnant mothers (HRPMs) visiting antenatal care (ANC) clinic at MDH. The availability of KMC at MDH was assessed using KMC availability checklist. The study used purposive, convenient and simple random sampling to identify eligible participants. Thematic analysis was used to analyze the findings.ResultsSixteen themes emerged on facilitating factors and barriers to accessibility and utilization of KMC service by the PLBWIs. The identified themes included; availability of KMC providers, social factor (social support and maternal love), timing of KMC information, knowledge on KMC, health linkage systems, recognition of LBWIs, safety on the use of KMC, preference of LBWI's care practice, lived experience on KMC practice, KMC expert clients, perceived causes of LBWI births, cultural/traditional factors, religious beliefs, health-seeking behavior, women empowerment and quality of care.ConclusionsAlthough KMC was available in some of the health facilities, integration of KMC messages in ANC guidelines, community awareness and in sensitization of any health intervention may enhance KMC accessibility and utilization by the targeted population.

Project description:BackgroundGlobally, about 15% of newborns are born with a low birth weight (LBW) as a result of preterm birth or intrauterine growth restriction or both. Up to 70% of neonatal deaths occur in this group within the first 3 days after birth. Kangaroo Mother Care (KMC) applied after stabilization of the infant has been shown to reduce mortality by 40% among hospitalized infants with a birth weight of less than 2.0 kg. In these studies, infants were randomly assigned and KMC was initiated after about 3 days of age, when the majority of neonatal deaths would have already occurred. The aim of this trial is to evaluate the safety and efficacy of continuous KMC initiated as soon as possible after birth compared with the current recommendation of initiating continuous KMC after stabilization in neonates with a birth weight between 1.0 and less than 1.8 kg.MethodsThis randomized controlled trial is being conducted in tertiary-care hospitals in five low- to middle-income countries (LMICs) in South Asia and sub-Saharan Africa. All pregnant women admitted to these hospitals for childbirth are pre-screened. After delivery, all neonates with a birth weight between 1.0 and less than 1.8 kg are screened for enrollment. Eligible infants are randomly assigned to intervention and control groups. The intervention consists of continuous skin-to-skin contact initiated as soon as possible after birth, promotion and support for early exclusive breastfeeding, and provision of health care for mother and baby with as little separation as possible. This efficacy trial will primarily evaluate the impact of KMC started immediately after birth on neonatal death (between enrollment and 72 h of age and deaths between enrollment and 28 days of age) and other key outcomes.DiscussionThis is the first large multi-country trial studying immediate KMC in LMICs. Implementation of this intervention has already resulted in an important enhancement of the paradigm shift in LMIC settings in which mothers are not separated from their baby in neonatal intensive care units (NICUs). The findings of this trial will have future global implications not only on how the LBW newborns are cared for immediately after birth but also for the dissemination of designing NICUs in accordance with the mother-neonatal intensive care unit (M-NICU) model.Trial registrationClinical Trials Registry - India (CTRI): CTRI/2018/08/01536 (retrospectively registered); Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12618001880235 (retrospectively registered).

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Is a woolen cap effective in maintaining normothermia in low-birth-weight infants during kangaroo mother care? Study protocol for a randomized controlled trial.

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Is a woolen cap effective in maintaining normothermia in low-birth-weight infants during kangaroo mother care? Study protocol for a randomized controlled trial.

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