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Completed

NCT Number: NCT02208960

Newborn Kit to Save Lives and Brains in Kenya

Each year, more than 3 million neonatal deaths occur worldwide and greater than 200 million children under the age of 5, almost all in low- and middle-income countries, are not fulfilling their developmental potential. The development of the growing brain can be affected through multiple mechanisms including the same insults that are major causes of mortality, namely hypothermia and infection. The first month of life is a crucial period in neurodevelopment (ND). In this study, the investigators propose the home-based use of an integrated evidence-based toolkit to improve health status, reduce the incidence of neonatal insults that may affect brain development, decrease neonatal mortality rate (NMR), and provide early identification of danger signs. The investigators hypothesize that use of the neonatal toolkit will result in an improvement of at least one standard deviation in neurodevelopment as measured at 12 months of age by the Protocol for Child Monitoring Infant and Toddler (PCM-IT) version.

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Key information

Conditions

Neurodevelopment Neonatal Mortality

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Aga Khan University

Nairobi, Kenya

About this study

Each year there are over 3 million global neonatal deaths. While significant progress has been made on overall under 5 mortality over the past decade, minimal progress has been made in reducing neonatal deaths and these now represent about 40% of all deaths in children under the age of 5. The majority of neonatal deaths occur in rural areas of developing countries and approximately two thirds are due to infection and complications relating to low birth weight (LBW) and prematurity. Additionally, more than 200 million children under 5 years old, almost all in low- and middle-income countries (LMIC), are not fulfilling their developmental potential. To date, most neonatal intervention trials in LMIC have focused on reducing mortality and little research has been performed on the consequences of severe but non-fatal neonatal insults on neurodevelopment (ND). Subsequently, little is known about interventions that may reduce the risk of long-term neurocognitive sequelae.

The first month of life is a critical period in ND in which there is significant neurogenesis, synaptogenesis, and myelination. Stimulation of the infant's brain during this period may have significant downstream positive effects. Development of the growing brain can be affected through multiple mechanisms including the same insults that are major causes of mortality, namely hypothermia and infection. Reducing the incidence of these insults during this period may not only save lives but also save brains and improve ND outcomes.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

i. All pregnant women in parts of study clusters covered by CHW program and their home- or facility-born live newborns.

ii. Mothers intending to maintain residence in study area for first 12 months of newborn's life.

Exclusion criteria

i. 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 battery-operated scale with suspended cloth sling. The scale will not be included with the kit but rather one will be issued to each Community Health Worker.

Neonatal Stimulation

Behavioral

A sub-set of children in the study will receive a neonatal stimulation program either on its own or in combination with the neonatal kit described above. The stimulation program will focus on teaching three key messages to enhance the caregivers' current caregiving practices, and each message is to be integrated into daily activities (e.g. during feeding, bathing, bedtime routines). By integrating the delivery of the interventions into the caregivers' daily routine, no additional time inconvenience will be added to their schedules. The key messages include:

  • Eye contact and talking to children
  • Responsive feeding and caregiving
  • Singing songs, including those with gentle touch

Primary outcomes

  1. Neurodevelopment as measured by the Protocol for Child Monitoring - Infant and Toddler version assessment

    Time frame: 12 months of age

    The Protocol for Child Monitoring - Infant and Toddler (PCM-IT) version was designed in Kenya to assess neurodevelopment in resource-limited settings.

Secondary outcomes

  1. Neonatal mortality

    Time frame: Day 1 (or as soon as possible after notification of birth), 3, 7, 14, and 28 of life

    Death from any cause within the first 28 days of life

  2. Incidence of omphalitis

    Time frame: Day 1 (or as soon as possible after notification of birth), 3, 7, 14, and 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)

  3. Incidence of severe infection

    Time frame: Day 1 (or as soon as possible after notification of birth), 3, 7, 14, and 28 of life

    Defined as:

    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.

  4. Cases of hypothermia identified

    Time frame: Day 1 (or as soon as possible after notification of birth), 3, 7, 14, and 28 of life

    Defined using ThermoSpot as:

    • Moderate hypothermia: pale green and red face (35ºC to 36ºC)
    • Severe hypothermia: black face (<35ºC)

  5. Cases of hyperthermia identified

    Time frame: Day 1 (or as soon as possible after notification of birth), 3, 7, 14, and 28 of life

    Defined using ThermoSpot as:

    Hyperthermia: blue face (>39ºC)

  6. Number of LBW babies identified

    Time frame: Day 1 (or as soon as possible after notification of birth), 3, 7, 14, and 28 of life

    LBW defined as: <2500 grams at first weighing

  7. Health facility use

    Time frame: Day 1 (or as soon as possible after notification of birth), 3, 7, 14, and 28 of life

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Collaborators

  • Aga Khan University
  • Grand Challenges Canada
  • March of Dimes

Registry information

Official study title

An Integrated Toolkit to Save Newborn Lives and Brains in Kenya

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Aug 5, 2014
Registry last updated
Jul 14, 2016

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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