effect of an integrated neonatal care kit on neonatal health outcomes: a cluster randomised controlled trial in rural pakistan

by:angelacrox     2020-07-07
Introduction, please.
In the first month of life, 6 million children died.
We evaluated the effectiveness of the integrated neonatal care kit (iNCK)
Newborn survival and other health outcomes in rural Pakistan.
We organized a community.
Random, pragmatic and open cluster-based
Label, control intervention trial of Rahim Yar Khan, Punjab province, Pakistan.
150 villages and their female health workers (LHWs)
, Delivered by random allocation of iNCK (intervention)
Or standard of care (control).
In the intervention cluster, LHWs provided iNCK and education on its use to pregnant women.
INCK contains a clean birth kit, a must-have, sunflower oil, continuous temperature monitor (ThermoSpot)
, Thermal reflection blanket and reusable hot bag.
LHWs also got helpheld scale.
INCK is mainly implemented by nursing staff.
The main result is
Death of newborn
Adjust according to cluster allocation and report results at a single level.
Admission from April 2014 to July 2015, participants follow up
Up ended on August 2015.
Results 5451 pregnant women (
Intervention and control of weapons accounted for 2663 and 2788, respectively)
Their 5286 live births
Intervention and control of weapons accounted for 2585 and 2701, respectively)were enrolled.
There were 147 neonatal deaths reported and 65 in the intervention group (25.
4 live births per 1000)
Compared with 82 in the control arm (30.
6 live births per 1000).
There was no significant difference in neonatal mortality between treatment groups (risk ratio 0. 83, 95% CI 0. 58 – 1. 18; p = 0. 30).
Conclusion of cooperation
A package of interventions directed at women did not significantly reduce neonatal mortality.
Further research is needed to improve compliance with expected iNCK usage.
Introduction to 2016 and 2.
In the first month of life, 6 million children died.
We evaluated the effectiveness of the integrated neonatal care kit (iNCK)
Newborn survival and other health outcomes in rural Pakistan.
We organized a community.
Random, pragmatic and open cluster-based
Label, control intervention trial of Rahim Yar Khan, Punjab province, Pakistan.
150 villages and their female health workers (LHWs)
, Delivered by random allocation of iNCK (intervention)
Or standard of care (control).
In the intervention cluster, LHWs provided iNCK and education on its use to pregnant women.
INCK contains a clean birth kit, a must-have, sunflower oil, continuous temperature monitor (ThermoSpot)
, Thermal reflection blanket and reusable hot bag.
LHWs also got helpheld scale.
INCK is mainly implemented by nursing staff.
The main result is
Death of newborn
Adjust according to cluster allocation and report results at a single level.
Admission from April 2014 to July 2015, participants follow up
Up ended on August 2015.
Results 5451 pregnant women (
Intervention and control of weapons accounted for 2663 and 2788, respectively)
Their 5286 live births
Intervention and control of weapons accounted for 2585 and 2701, respectively)were enrolled.
There were 147 neonatal deaths reported and 65 in the intervention group (25.
4 live births per 1000)
Compared with 82 in the control arm (30.
6 live births per 1000).
There was no significant difference in neonatal mortality between treatment groups (risk ratio 0. 83, 95% CI 0. 58 – 1. 18; p = 0. 30).
Conclusion of cooperation
A package of interventions directed at women did not significantly reduce neonatal mortality.
Further research is needed to improve compliance with expected iNCK usage.
What is known?
There is no evidence of the effectiveness of integrated neonatal intervention programmes that community health workers can provide and are implemented by women and families in improving newborn health outcomes.
What is the new discovery?
In this community
Cluster-based, random and pragmatic (effectiveness), open-
Label, control intervention trial, no significant difference in neonatal mortality between interventions (25.
4 live births per 1000)
And control group (30.
6 live births per 1000).
Implementation of nursing staff in integrated neonatal care kits (iNCK)
Effectively reducing the risk of umbilical inflammation that may be predicted or preceded by severe infection, and enabling caregivers to identify and take action to address issues of fever, cold stress, and low body temperature, symptoms that may indicate a serious condition.
What does New discovery mean?
And the integration of evidence --
Interventions based on women and family implementation are a promising idea with several advantages, early absorption of some iNCK components is a challenge, and interventions do not statistically significantly reduce neonatal mortality.
It is necessary to further study the actual impact of iNCK, including strategies to improve compliance of caregivers with the intended use of the iNCK component.
Introduction 2016, estimated 2.
There are 6 million neonatal deaths worldwide, accounting for 46% of the total number of deaths among children under 5 years of age.
The third Sustainable Development Goal (SDG3)
The goal that all countries should commit to reducing neonatal mortality (NMRs)
By 2030, there were no more than 12 deaths per 1000 live births.
In order to achieve this goal, the scale of accelerationRise of community
Basic interventions to effectively reduce neonatal deaths must be taken.
Pakistan has 46 newborn deaths per 1000 live births, the highest MRI in South Asia and the world.
The main cause of neonatal death in Pakistan in 2015 was premature birth (39%)
Birth suffocation and trauma (21%)and sepsis (17%).
If the average annual growth rate of NMR remains unchanged, Pakistan will not be able to achieve the SDG3 target by 2081. Evidence-
Basic interventions to improve newborn survival
However, their coverage is low, especially in rural communities, where many births and newborn deaths occur at home.
6 while some newborn interventions are bundled in the package, there are very few packages provided by community health workers (CHWs)
And less is strictly assessed.
One notable exception is the training and evaluation of traditional midwives in rural Zambia to manage common perinatal conditions that lead to a marked decline in neonatal ethics, especially in the first 24 hours of life.
Given that CHWs was not able to reach the newborn shortly after birth, 11 efforts were needed to make pregnant women and families the implementers of newborn interventions.
The neonatal intervention programme implemented by CHWs for women and families has the potential to continuously reduce neonatal mortality.
We organized a community.
Cluster-based randomized controlled trials to determine the effectiveness of providing a comprehensive neonatal care kit (iNCK)
And through the existing cadre of female health workers, educate pregnant women and their families to use it (LHWs)
Neonatal mortality rate
In Pakistan, LHWs is an important link between the health system and the community;
Each LHW provides primary care for approximately 200 households in rural areas and urban slums.
LHWs provided participants with iNCK and education on their use.
INCK contains a clean birth kit (CBK)
, 4% chlorhexidine solution, Sunflower Oil Moisturizer, temperature indication label (ThermoSpot)
, Thermal reflective polyester blanket and reusable hot wrap.
LHWs delivered to Inca also got help
Electronic said.
Each iNCK component is selected on the basis of the following evidence: it reduces the incidence of newborns, 13-18 years of age, or it is possible to provide early identification of signs of danger, 19-21 or enable caregivers to manage Hazard signals until health care is reached.
22 methods, research, design, and supervision.
Based on layered random, pragmatic (effectiveness), open-
Label, controllable, parallel double
Arm intervention test of Rahim Yar Khan (RYK)
From April 2014 to August 2015, Pakistan.
Clusters are defined as villages and their associated LHWs.
The protocol consists of two stages of work, 11 months apart, with different time and frequency of data collection access.
The results of the first phase are reported, during which families are frequently visited to collect data on compliance and results.
The study programme for the first phase of the trial has previously been published 22 and has been approved by the research ethics committee of the Hospital for Sick Children (REB No. 100042963)
National Committee on Bioethics of Pakistan (No. 4-87/13/NBC-133/RDC/2629).
An independent data and security monitoring committee reviewed the bi-weekly progress report and blind interim analysis covering the period April 2014-February 2015.
The trial has been registered in clinical trials. gov (NCT02130856).
Detailed learning methods and protocol modifications (
Online supplementary form S1)
The online Supplementary Appendix is included.
Supplementary information [bmjgh-2019-001393supp001. pdf]
Participants and procedures all late-stage pregnant women involved in the randomized grouping are considered qualified if they intend to stay in the study catchment area for at least one month after delivery.
The involved LHWs identified the pregnant woman and informed the study team.
A data collector visited pregnant women, explained the study and collected informed consent forms.
LHW delivered standards for carek and/or care12 (
Online Supplementary Panel 1).
LHWs teaches pregnant women how to use each iNCK ingredient and is instructed to restate iNCK education during postpartum visits.
However, the study did not motivate or monitor postpartum visits to LHWs.
In this study, LHWs did not receive financial compensation.
In order to encourage timely notification of birth, small monetary rewards were provided to the first person who reported the delivery to the research team.
Prospective follow-up of all live newborns.
Supplementary information [bmjgh-2019-001393supp002. pdf]
Data collectors, in intervention and control clusters, visit the participant\'s home as soon as possible for 3, 7, 14 and 28 days after delivery.
At the first visit, events before and after delivery and postpartum status of the newborn were recorded.
In subsequent visits, the results achieved since the last visit were recorded.
All questionnaires were conducted as structured interviews.
Newborn babies are weighed on the day of admission, 7 days and 28 days.
The data collection personnel were trained to identify the risk signal of the newborn (
Supplementary Appendix online)
The case was handed over to the facility.
In order to minimize the complexity of the operation while putting data collection as close as possible to the priority of delivery, the birth notified after the third day is only accessed 28 days or after;
Data on pregnancy outcomes, iNCK use, and newborn life status were collected in these visits.
If a newborn is dead or stillborn, try an oral autopsy.
Interventik contains a CBK (
Gloves, soap, clean plastic sheets, sterile blades and wire clips)
, 4% chlorhexidine solution, Sunflower Oil Moisturizer, continuous temperature indicator (ThermoSpot)
, Polyester blankets and instant hot packs (
Online Supplementary Panel 1).
At the time of iNCK delivery, LHWs individually taught expectant mothers how to use each iNCK ingredient.
If there are other nursing staff (ie, mother-in-
Law, father, etc)
The teaching meeting was also attended.
Pregnant women are instructed to bring the entire Inca to the factory at the time of delivery.
In the case of family delivery, the mother was told to provide the CBK to the midwife.
Pregnant women were told to apply chlorhexidine once a day from the first day to the tenth day at the residual end of the umbilical cord, and to attach a hot spot sticker to the skin on the artery on the first day until 14 days.
Women are told what each sticker color means and what action will be taken if hot spots show fever, cold or low body temperature.
From Day 3 to day 28, sunflower oil is massaged once a day on the newborn.
The cost of purchasing and assembling each Inca is approximately $10;
However, on scale, iNCK\'s components can be purchased and assembled for less than $5.
LHWs in intervention cluster got hands
Maintain the scale and be instructed to weigh during the first postpartum examination of the newborn and refer to the low birth weight (LBW)babies (
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