Clinical trial NCT02130856: Newborn Kit to Save Lives in Pakistan
Official title: An Integrated Toolkit to Save Newborn Lives in Pakistan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neonatal Mortality
Keywords: Neonatal mortality
Neonatal kit
Pakistan
Randomized Control Trial
Chlorhexidine
ThermoSpot
Birth
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Grand Challenges Canada
name: UBS Optimus Foundation
name: Mother and Child Care Trust (MCCT), Pakistan
name: Aga Khan University
name: March of Dimes
First posted: 2014-05-05
Enrollment: 8518
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: There are over 3 million annual neonatal deaths. Approximately 2/3 of neonatal deaths are due to infection, low birth weight (LBW), and prematurity. Low tech but high impact interventions and commodities used in unconventional ways could save hundreds of thousands of newborn lives. We propose an integrated evidence-based toolkit usable by community health workers (CHW) to reduce neonatal deaths. The kit will include: Chlorhexidine to be applied to the umbilical stump, sunflower oil emollient to be applied to the skin, ThermoSpot to identify hypo/hyperthermia, and a Mylar infant sleeve with non-electric warmer.

Detailed description: Over 3 million global neonatal deaths are reported annually. While significant progress has been made over the past decade towards reducing overall under 5 mortality, very little progress has been made towards the reduction of neonatal deaths, which represent about 40% of all deaths in children under the age of 5. The majority of neonatal deaths occur in rural areas of low-income countries and approximately two thirds are due to infection and complications relating to low birth weight (LBW) and prematurity.

In Pakistan, it is estimated that over 200,000 newborns die each year before they reach the end of their first month of life, representing nearly 58% of all deaths among children under the age of five. The risk of neonatal death in Pakistan is higher in rural areas than in urban areas; the neonatal mortality rate (NMR) in rural areas is 55 per 1,000 live births compared to 48 per 1,000 live births in urban areas. NMR in Pakistan is also associated with poverty; the NMR in highest wealth quintile is 38 compared to 63 per 1000 live births in lowest wealth quintile.

In resource poor settings, newborns are most often delivered at home and receive minimal specific medical care, measurement, or monitoring. In these areas, geography, infrastructure, and poverty often effectively prevent access to health centers and care. Home outreach with trained Community health workers (CHWs) is increasingly recognized as the mainstay for provision of maternal and newborn care in these settings. Many proven, cost-effective ways to save the lives of newborns exist, however, they are not always available to those who need them most nor have they been packaged into a single portable kit that can be easily used in the home-setting. Such a portable kit consisting of low cost, evidence-based interventions for use in the home has tremendous potential to improve health status and decrease NMR.

In this study, the investigators hypothesize that the implementation of an integrated evidence-based toolkit by CHWs will reduce neonatal deaths by at least 40% through a reduction in both infectious causes of death and those associated with prematurity and LBW. Furthermore, the investigators propose that there will be an additive effect from the mortality benefit of specific kit components. The portable kit will contain a clean birth kit to be used at the time of delivery either at home or in a facility, 4% chlorhexidine (CHX) lotion, sunflower oil emollient, ThermoSpot, a Mylar infant sleeve, and a reusable, non-electric, heating device. CHWs will be equipped with a hand held electric scale to identify LBW newborns.

Eligibility criteria: Inclusion Criteria:

* All pregnant women in parts of study clusters covered by Lady Health Worker program and their home- or facility-born live newborns
* Mother intending to maintain residence in study area for first month of newborn's life

Exclusion Criteria:

* Failure to provide consent to enroll in study (intervention or control clusters)

Primary outcomes:
measure: Neonatal mortality
timeFrame: During phase I of the study: Day 1 (or as soon as possible after notification of birth), 3, 7, 14, and 28 of life. During phase II of the study: Day 8 and day 28 of life.
Secondary outcomes:
measure: Incidence of omphalitis
timeFrame: During phase I of the study: Day 1 (or as soon as possible after notification of birth), 3, 7, 14, and 28 of life. During phase II of the study: Day 8 and day 28 of life.
measure: Incidence of severe infection
timeFrame: During phase I of the study: Day 1 (or as soon as possible after notification of birth), 3, 7, 14, and 28 of life. During phase II of the study: Day 8 and day 28 of life.
measure: Cases of hypothermia identified
timeFrame: During phase I of the study: Day 1 (or as soon as possible after notification of birth), 3, 7, 14, and 28 of life. During phase II of the study: Day 8 and day 28 of life.
measure: Cases of hyperthermia identified
timeFrame: During phase I of the study: Day 1 (or as soon as possible after notification of birth), 3, 7, 14, and 28 of life. During phase II of the study: Day 8 and day 28 of life.
measure: Number of low birth weight (LBW) newborns identified
timeFrame: During phase I of the study: Day 1 (or as soon as possible after notification of birth), 3, 7, 14, and 28 of life. During phase II of the study: Day 8 and day 28 of life.
measure: Health Facility Use
timeFrame: During phase I of the study: Day 1 (or as soon as possible after notification of birth), 3, 7, 14, and 28 of life. During phase II of the study: Day 8 and day 28 of life.
measure: Neurodevelopmental score at 12 months of age
timeFrame: Month 12 of life (only during phase I of the study)
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Aga Khan University
Study officials:
affiliation: The Hospital for Sick Children, Toronto
name: Shaun K. Morris, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Aga Khan University
name: Zulfiqar A. Bhutta, PhD, MBBS
role: PRINCIPAL_INVESTIGATOR
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