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Completed

NCT Number: NCT02130856

Newborn Kit to Save Lives in Pakistan

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.

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Key information

Conditions

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Aga Khan University

Karachi, 74800, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Neonatal Kit

Device

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.

Primary outcomes

  1. Neonatal mortality

    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

Secondary outcomes

  1. Incidence of omphalitis

    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:

    • 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)
  2. Incidence of severe infection

    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.

  3. Cases of hypothermia identified

    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:

    • Moderate hypothermia: pale green and red face (35C to 36C)
    • Severe hypothermia: black face (<35C)
  4. Cases of hyperthermia identified

    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)

  5. Number of low birth weight (LBW) newborns identified

    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

  6. Health Facility Use

    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.

  7. Neurodevelopmental score at 12 months of age

    Time frame: Month 12 of life (only during phase I of the study)

    Assessed by the Bayley Scale of Infant Development III (BSID III).

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Collaborators

  • Aga Khan University
  • Grand Challenges Canada
  • March of Dimes
  • Mother and Child Care Trust (MCCT), Pakistan
  • UBS Optimus Foundation

Registry information

Official study title

An Integrated Toolkit to Save Newborn Lives in Pakistan

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
May 5, 2014
Registry last updated
Apr 25, 2017

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.

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