Newborn Kit to Save Lives in Pakistan
- Conditions
- Neonatal Mortality
- Interventions
- Device: Neonatal kit
- Registration Number
- NCT02130856
- Lead Sponsor
- The Hospital for Sick Children
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 8518
- 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
- Failure to provide consent to enroll in study (intervention or control clusters)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Neonatal Kit Neonatal kit The neonatal 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. Lady Health Workers will be equipped with a hand held electric scale to identify low birth weight newborns.
- Primary Outcome Measures
Name Time Method Neonatal mortality 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. Death from any cause within the first 28 days of life
- Secondary Outcome Measures
Name Time Method Incidence of severe infection 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. Incidence of severe infection is defined as:
a) Convulsions OR fast breathing (60 breaths per minute or more) OR severe chest indrawing OR movement only when stimulated or no movement at all OR not feeding at all for at least 12 hours.Cases of hypothermia identified 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. Hypothermia defined using ThermoSpot as:
1. Moderate hypothermia: pale green and red face (35C to 36C)
2. Severe hypothermia: black face (\<35C)Cases of hyperthermia identified 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. Hyperthermia defined using ThermoSpot as:
a) Hyperthermia: blue face (\>39C)Neurodevelopmental score at 12 months of age Month 12 of life (only during phase I of the study) Assessed by the Bayley Scale of Infant Development III (BSID III).
Incidence of omphalitis 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. Incidence of omphalitis where omphalitis is defined as:
1. None (no redness or swelling)
2. Mild (inflammation limited to the cord stump)
3. Moderate (inflammation extending less than 2cm to the skin at the base of the cord stump)
4. Severe (inflammation extending more than 2cm from the cord stump)Number of low birth weight (LBW) newborns identified 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. LBW is defined as:
\<2500 grams at first weighingHealth Facility Use 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.
Trial Locations
- Locations (1)
Aga Khan University
🇵🇰Karachi, Pakistan