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Effect of an integrated neonatal care kit on neonatal health outcomes: a cluster randomised controlled trial in rural Pakistan.

ABSTRACT: Introduction:In 2016, 2.6 million children died during their first month of life. We assessed the effectiveness of an integrated neonatal care kit (iNCK) on neonatal survival and other health outcomes in rural Pakistan. Methods:We conducted a community-based, cluster randomised, pragmatic, open-label, controlled intervention trial in Rahim Yar Khan, Punjab, Pakistan. Clusters, 150 villages and their lady health workers (LHWs), were randomly assigned to deliver the iNCK (intervention) or standard of care (control). In intervention clusters, LHWs delivered the iNCK and education on its use to pregnant women. The iNCK contained a clean birth kit, chlorhexidine, sunflower oil, a continuous temperature monitor (ThermoSpot), a heat reflective blanket and reusable heat pack. LHWs were also given a hand-held scale. The iNCK was implemented primarily by caregivers. The primary outcome was all-cause neonatal mortality. Outcomes are reported at the individual level, adjusted for cluster allocation. Enrolment took place between April 2014 and July 2015 and participant follow-up concluded in August 2015. Results:5451 pregnant women (2663 and 2788 in intervention and control arms, respectively) and their 5286 liveborn newborns (2585 and 2701 in intervention and control arms, respectively) were enrolled. 147 newborn deaths were reported, 65 in the intervention arm (25.4 per 1000 live births) compared with 82 in the control arm (30.6 per 1000 live births). Neonatal mortality was not significantly different between treatment groups (risk ratio 0.83, 95% CI 0.58 - 1.18; p = 0.30). Conclusion:Providing co-packaged interventions directly to women did not significantly reduce neonatal mortality. Further research is needed to improve compliance with intended iNCK use.

SUBMITTER: Pell LG

PROVIDER: S-EPMC6528753 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Effect of an integrated neonatal care kit on neonatal health outcomes: a cluster randomised controlled trial in rural Pakistan.

Pell Lisa G LG Turab Ali A Bassani Diego G DG Shi Joy J Soofi Sajid S Hussain Masawar M Ariff Shabina S Bhutta Zulfiqar A ZA Morris Shaun K SK

BMJ global health 20190516 3

<h4>Introduction</h4>In 2016, 2.6 million children died during their first month of life. We assessed the effectiveness of an integrated neonatal care kit (iNCK) on neonatal survival and other health outcomes in rural Pakistan.<h4>Methods</h4>We conducted a community-based, cluster randomised, pragmatic, open-label, controlled intervention trial in Rahim Yar Khan, Punjab, Pakistan. Clusters, 150 villages and their lady health workers (LHWs), were randomly assigned to deliver the iNCK (interventi ...[more]

PMID: 31179036

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Project description:BACKGROUND:The United Nation's Sustainable Development Goals encompass lifelong learning from birth to youth to adulthood (Goal 4) and economic opportunities for young people (Goal 8). The targets include improving access to quality early childhood care and education (ECCE) as well as learning and training opportunities for adolescents and youth. Cross-generational models for young children and youth may offer opportunities to address the interconnections between goals and targets for the next generation. We investigated whether an ECCE programme for young children (3.5-6.5 years) delivered by female youth (18-24 years) in rural Pakistan would be effective on children's school readiness. METHODS:In partnership with the National Commission for Human Development in Pakistan, we implemented the 'Youth Leaders for Early Childhood Assuring Children are Prepared for School' (LEAPS) programme to train female youth to deliver ECCE. The effectiveness of the LEAPS programme on children's school readiness was evaluated in a cluster-randomised controlled trial. We randomly allocated five clusters (villages) to receive the intervention (n = 170 children) and five clusters to control (n = 170 children). Children's school readiness was assessed after nine months of intervention exposure using the International Development and Early Learning Assessment tool. Analyses was by intention-to-treat. The trial is registered with ClinicalTrials.gov, number NCT02645162. FINDINGS:At endline, the intervention group had significantly higher school readiness scores (n = 166, mean percentage score 59.4, 95% CI 52.7 to 66.2) compared with the control group (n = 168, mean percentage score 45.5, 95% CI 38.8 to 52.3). The effect size (Cohen's d) was 0.3. CONCLUSION:Trained female youth delivered an ECCE programme that was effective in benefitting young children's school readiness. The cross-generational model is a promising approach to support early child development; however, further evaluation of the model is needed to assess the specific benefits to youth including their skills and economic development.

Project description:Worldwide, an estimated 2.9 million neonatal deaths occurred in 2012, accounting for 44% of all under-five deaths. In Pakistan, more than 200,000 newborns die annually and neonatal mortality rates are higher than in any other South Asian country and haven't changed over the last three decades. The high number of neonatal deaths highlights the urgent need for effective and sustainable interventions that target newborn mortality in Pakistan.This cluster randomized trial aims at evaluating the impact of delivering an integrated neonatal kit to pregnant women during the third trimester of pregnancy and providing education on how to use the contents (intervention arm) compared to the current standard of care (control arm) in the district of Rahimyar Khan, Punjab province, Pakistan. The kit, which will be distributed through the national Lady Health Worker program, comprises a clean delivery kit (sterile blade, cord clamp, clean plastic sheet, surgical gloves and hand soap), sunflower oil emollient, chlorhexidine, ThermoSpot™, Mylar infant sleeve, and a reusable instant heat pack. Lady health workers will be provided with a standard portable hand-held electric weighing scale. The primary outcome measure is neonatal mortality (death in the first 28 days of life).While many cost-effective, evidence-based interventions to save newborn lives exist, they are not always accessible nor have they been integrated into a portable kit designed for home-based implementation entirely by caregivers. The implementation of cost-effective, portable, and easy-to-use interventions has tremendous potential for sustainably reducing neonatal mortality and long-term improvements in population health. The bundling of interventions and commodities together also has much potential for cost-effective delivery and maximizing gains from points of contact. This study will provide empirical evidence on the feasibility and effectiveness of the delivery of an innovative neonatal kit to pregnant women in Pakistan. Together, these findings will help inform policy on the most appropriate interventions to improve newborn survival.ClinicalTrial.gov NCT02130856. Registered May 1, 2014.

Project description:BackgroundAlthough the effectiveness of community mobilisation and promotive care delivered by community health workers in reducing perinatal and neonatal mortality is well established, evidence in support of home-based neonatal resuscitation and infection management is mixed. We assessed the effectiveness of adding training in neonatal bag and mask resuscitation and oral antibiotic therapy for suspected neonatal infections to a basic preventive and promotive interventions package delivered by public sector community-based lady health workers (LHWs) in rural Pakistan.MethodsWe did a cluster-randomised controlled trial in two subdistricts of Naushahro Feroze in rural Sindh, Pakistan, between April 15, 2009, and Dec 10, 2012. LHWs, trained in basic newborn resuscitation and in recognition and treatment (with oral amoxicillin) of suspected neonatal respiratory infections, were linked with traditional birth attendants and encouraged to attend home births. Control clusters received routine care through the existing national programme. The primary outcome was all-cause neonatal mortality. Independent data collection teams recorded data for all pregnancies and their outcomes, morbidity, mortality, and household practices related to maternal and newborn care.FindingsOf the 27 randomised clusters with functional LHW programmes, 13 were allocated to the intervention group (n=242 749) and 14 to the control group (n=256 985). In the intervention group, LHWs did 80% of the planned community mobilisation sessions, but were able to attend only 1184 (14%) of 8425 deliveries and 4318 (25%) of 17 288 neonatal visits within 72 h of birth (p<0·0001 for both variables compared with the control group). The neonatal mortality rate was 42 deaths per 1000 livebirths in intervention clusters compared with 55 per 1000 in the control group (risk ratio 0·80, 95% CI 0·68-0·93; p=0·005).InterpretationThe reduction in neonatal mortality in intervention clusters occurred against a background of improvements in domiciliary practices for maternal and newborn care. However, the poor reach of LHWs in accessing newborn infants at birth and in the early postnatal period underscores the limitations of tasking community health workers in public sector programmes working in similar circumstances with such complex interventions. Such community-based interventions in health systems should be accompanied by concerted efforts to improve quality of care in facilities and referral systems.FundingSaving Newborn Lives, Save the Children USA.

Project description:IntroductionEmotional problems are leading contributors to health burden among adolescents worldwide. There is an urgent need for evidence-based psychological interventions for young people. This study aims to evaluate the effectiveness of a school-based, group psychological intervention, Early Adolescent Skills for Emotions (EASE) developed by the WHO to improve psychosocial distress in Pakistani adolescents.Method and analysisA two-arm, single-blinded, cluster randomised controlled trial, with a wait-list control arm is being conducted in school settings of rural Pakistan. Forty eligible public-school clusters have been randomised (stratified by gender) on a 1:1 allocation ratio into intervention (n=20) and control arm (n=20). Following informed consent, 564 adolescents with psychosocial distress (Youth-reported Paediatric Symptoms Checklist, cut-off ≥28) from 40 schools have been enrolled into the trial (14±3 average cluster size) between 2 November 2021 and 30th November 2021. Participants in the intervention arm will receive EASE in 7-weekly adolescents and 3-biweekly caregivers group sessions in schools. The adolescent sessions involve the components of psychoeducation, stress management, behavioural activation, problem-solving and relapse prevention. Caregivers will receive training to learn and implement active listening; spending quality time and using praise as a strategy to help their children. The primary outcome is reduction in psychosocial distress at 3 months postintervention. Secondary outcomes include symptoms of depression and anxiety, caregiver-adolescent relationship and caregivers' well-being. Outcomes will be assessed at baseline, immediate 1 week and 3-months postintervention. Qualitative process evaluation will explore barriers and facilitators to programme implementation in low-resource school settings.EthicsEthics approval has been obtained from Central Ethics Committee of University of Liverpool, UK, Ethics Review Committee of WHO Geneva and from the Institutional Review Board of Human Development Research Foundation (HDRF), Pakistan.DisseminationThe findings of the study will be disseminated by WHO and through peer-reviewed publications.Trial registration numberISRCTN17755448.

Project description:BACKGROUND:The burden of maternal and neonatal mortality remains persistently high in Nigeria. Sepsis contributes significantly to both maternal and newborn mortality, and safe delivery kits have long been promoted as a cost-effective intervention to ensure hygienic delivery practices and reduce sepsis. However, there is limited evidence on the effectiveness of home birth kit distribution by community health workers, and particularly the impact of this intervention on health outcomes. This paper reports a secondary analysis of data from a cluster randomized trial in rural northern Nigeria in which birth kits were distributed by community health workers to pregnant women in their homes, analyzing non-experimental variation in receipt and use of birth kits. More specifically, associations between pregnant women's baseline characteristics and receipt and use of birth kits, and associations between birth kit use, care utilization and maternal and newborn outcomes were assessed. METHODS AND FINDINGS:Baseline, post-birth and endline data related to 3,317 births observed over a period of three years in 72 intervention communities in Jigawa state, Nigeria, were analyzed using hierarchical, logistic regression models. In total, 140 women received birth kits, and 72 women used the kits. There were no associations between baseline demographic characteristics, health history, and knowledge and attitudes and receipt of a kit, suggesting that community health workers did not systematically target the distribution of birth kits. However, women who used the kit reported reduced odds of past pregnancy complications (OR = 0.44, 95% CI: 0.19-1.00) as well as significantly higher odds of feeling generally healthy at baseline (OR = 2.00, 95% CI: 1.06-3.76), of exposure to radio media (OR = 1.97, 95% CI: 1.21-3.22), and of perceiving themselves as having a low-risk pregnancy (OR = 3.05, 95% CI:1.39-6.68). While there were no significant associations between birth kit use and facility based delivery, skilled birth attendance or post-natal care, women who used a kit exhibited significantly lower odds of completing four or more ANC visits (adjusted OR = 0.39, 95% CI: 0.18-0.85) and significantly higher odds of reporting prolonged labor (adjusted OR = 4.75, 95% CI: 1.36-16.59), and post-partum bleeding (adjusted OR = 3.25, 95% CI: 1.11-9.52). CONCLUSIONS:This evidence suggests that use of birth kits is low in a rural population characterized by minimal baseline utilization of maternal and neonatal health services, and the use of birth kits was not associated with reductions in maternal or neonatal morbidity. While further research is required to understand how the effectiveness of birth kits may be shaped by the mechanism through which women access and utilize the kits, our findings suggest that the provision of kits to women outside of the formal health system may be associated with increased risk of adverse outcomes.

Project description:BackgroundNeonatal mortality due to preterm birth and low birthweight remains a significant challenge in Pakistan. Kangaroo mother care (KMC) is a unique, low-cost intervention proven to reduce neonatal mortality and morbidity and increase exclusive breastfeeding rates. However, KMC has not been attempted in community settings in Pakistan. We aim to implement and evaluate the effectiveness of a community-based KMC package to reduce neonatal morbidity and mortality among preterm and low birthweight (LBW) infants, which will provide evidence for policy development and the large-scale implementation of KMC across the country.ObjectiveThe primary objective of this trial is to reduce neonatal mortality among preterm and LBW infants. The secondary objectives are growth (measured as weight gain), reduced incidence of possible serious bacterial infection, and increased exclusive breastfeeding and continued breastfeeding practices.MethodsWe designed a community-based cluster randomized controlled trial in one rural district of Pakistan. Stable, LBW babies (weighing 1200 grams to 2500 grams) are included in the study. The community KMC package, consisting of the KMC kit, information and counseling material, and community mobilization through KMC champions (village volunteers), was designed after preliminary research in the same geographical location and implemented in intervention clusters. The standard essential newborn care is offered in the control clusters. Infants are recruited and followed up by independent teams of data collectors. Data are collected on the duration of skin-to-skin contact, growth, breastfeeding practices, morbidities, neonatal mortality, and neurodevelopment status. Data analysis will be conducted based on the intention to treat principle. The Cox regression model will be used to assess the primary outcome of neonatal mortality. The secondary outcomes will be evaluated using linear or logistic regression.ResultsThe Ethics Review Committee of Aga Khan University, Pakistan, approved the study protocol in February 2017. Data collection began in August 2019 and will be completed in December 2021. Data analyses are yet to be completed.ConclusionsThis intervention may be effective in preventing sepsis and subsequently improve survival in LBW newborns in Pakistan and other low-income and middle-income countries worldwide.Trial registrationclinicaltrials.gov NCT03545204; https://clinicaltrials.gov/ct2/show/NCT03545204.International registered report identifier (irrid)DERR1-10.2196/28156.

Project description:BackgroundPakistan faces huge challenges in eradicating polio due to widespread poliovirus transmission and security challenges. Innovative interventions are urgently needed to strengthen community buy-in, to increase the coverage of oral polio vaccine (OPV) and other routine immunisations, and to enhance immunity through the introduction of inactivated polio vaccine (IPV) in combination with OPV. We aimed to evaluate the acceptability and effect on immunisation coverage of an integrated strategy for community engagement and maternal and child health immunisation campaigns in insecure and conflict-affected polio-endemic districts of Pakistan.MethodsWe did a community-based three-arm cluster randomised trial in healthy children aged 1 month to 5 years that resided within the study sites in three districts of Pakistan at high risk of polio. Clusters were randomly assigned by a computer algorithm using restricted randomisation in blocks of 20 by an external statistician (1:1:1) to receive routine polio programme activities (control, arm A), additional interventions with community outreach and mobilisation using an enhanced communication package and provision of short-term preventive maternal and child health services and routine immunisation (health camps), including OPV (arm B), or all interventions of arm B with additional provision of IPV delivered at the maternal and child health camps (arm C). An independent team conducted surveys at baseline, endline, and after each round of supplementary immunisation activity for acceptability and effect. The primary outcome measures for the study were coverage of OPV, IPV, and routine extended programme on immunisation vaccines and changes in the proportion of unvaccinated and fully vaccinated children. This trial is registered with ClinicalTrials.gov, number NCT01908114.FindingsBetween June 4, 2013, and May 31, 2014, 387 clusters were randomised (131 to arm A, 127 to arm B, and 129 to arm C). At baseline, 28 760 children younger than 5 years were recorded in arm A, 30 098 in arm B, and 29 126 in arm C. 359 clusters remained in the trial until the end (116 in arm A, 120 in arm B, and 123 in arm C; with 23 334 children younger than 5 years in arm A, 26 110 in arm B, and 25 745 in arm C). The estimated OPV coverage was 75% in arm A compared with 82% in arm B (difference vs arm A 6·6%; 95% CI 4·8-8·3) and 84% in arm C (8·5%, 6·8-10·1; overall p<0·0001). The mean proportion of routine vaccine doses received by children younger than 24 months of age was 43% in arm A, 52% in arm B (9%, 7-11) and 54% in arm C (11%, 9-13; overall p<0·0001). No serious adverse events requiring hospitalisation were reported after immunisation.InterpretationDespite the challenges associated with the polio end-game in high-risk, conflict-affected areas of Pakistan, a strategy of community mobilisation and targeted community-based health and immunisation camps during polio immunisation campaigns was successful in increasing vaccine coverage, including polio vaccine coverage.FundingBill & Melinda Gates Foundation.

Dataset Information

Effect of an integrated neonatal care kit on neonatal health outcomes: a cluster randomised controlled trial in rural Pakistan.

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Effect of an integrated neonatal care kit on neonatal health outcomes: a cluster randomised controlled trial in rural Pakistan.

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