Aga Khan University
Karachi, 74800, Pakistan
NCT Number: NCT02130856
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.
Looking for future studies?
Notify MeFemale
Interventional
Phase 3
Karachi, 74800, Pakistan
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Contents of the neonatal kit:
Time frame: 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
Time frame: 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:
Time frame: 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.
Time frame: 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:
Time frame: 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)
Time frame: 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 weighing
Time frame: 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.
Time frame: Month 12 of life (only during phase I of the study)
Assessed by the Bayley Scale of Infant Development III (BSID III).
The Hospital for Sick Children
Other
An Integrated Toolkit to Save Newborn Lives in Pakistan
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04798833
Female Urogenital Diseases and Pregnancy Complications, Hemorrhage
Islamabad, Pakistan
View Trial DetailsNCT00148629
Anemia, Birth Weight
Wawi, Zanzibar, Tanzania
View Trial DetailsNCT06729398
Brain Diseases, Cardiovascular Diseases
Jakarta, Indonesia
View Trial DetailsNCT06685679
Cardiovascular Diseases, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Cairo, Egypt
View Trial Details