Newborn Kit to Save Lives in Pakistan

Study Overview
=================
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.

Official Title
-----------------
An Integrated Toolkit to Save Newborn Lives in Pakistan

Conditions
-----------------
Neonatal Mortality

Intervention / Treatment
-----------------
* Device: Neonatal kit


Participation Criteria
=================
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)
Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neonatal Kit<br>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. | Device: Neonatal kit<br>* Contents of the neonatal kit: Clean birth kit: sterile blade, a clean plastic square, plastic gloves, hand soap, and cord ties/clamp. 4% Chlorhexidine (CHX) lotion (15 mL) and a bag of cotton balls. Sunflower oil emollient (50 mL) ThermoSpot Mylar infant sleeve Click to heat warmer (http://www.heatinaclick.ca/products/pocket_size.html) in a fitted cloth pouch. Handheld electric scale with suspended cloth sling. The scale will not be included with the kit but rather one will be issued to each Lady Health Worker.<br>|
| No Intervention: Control (Standard care)<br>In the control arm, Lady Health Workers will visit the home according to the regular schedule (same as in the intervention clusters) and will deliver the standard post-natal care consisting of: be present at delivery (though not conduct the delivery) and thorough examination of newborn and mother post delivery check mother for vaginal bleeding and abnormal blood pressure and make referral to nearest health facility as appropriate refer any newborn with congenital anomaly or evidence of asphyxia if unable to attend delivery for any reason, visit within first 24 hours post delivery assess newborn in first month of life during visits and provide basic treatment for acute respiratory infections, pneumonia, and diarrhea in the home encourage breastfeeding | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neonatal mortality | Death from any cause within the first 28 days of life | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of omphalitis | Incidence of omphalitis where omphalitis is defined as: None (no redness or swelling) Mild (inflammation limited to the cord stump) Moderate (inflammation extending less than 2cm to the skin at the base of the cord stump) Severe (inflammation extending more than 2cm from the cord stump) | 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 | 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. | 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. | 
| Cases of hypothermia identified | Hypothermia defined using ThermoSpot as: Moderate hypothermia: pale green and red face (35C to 36C) Severe hypothermia: black face (<35C) | 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. | 
| Cases of hyperthermia identified | Hyperthermia defined using ThermoSpot as: a) Hyperthermia: blue face (>39C) | 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. | 
| Number of low birth weight (LBW) newborns identified | LBW is defined as: <2500 grams at first weighing | 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. | 
| Health 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. | 
| Neurodevelopmental score at 12 months of age | Assessed by the Bayley Scale of Infant Development III (BSID III). | Month 12 of life (only during phase I of the study) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neonatal mortality, Neonatal kit, Pakistan, Randomized Control Trial, Chlorhexidine, ThermoSpot, Birth