Newborn Kit to Save Lives and Brains in Kenya

July 13, 2016 updated by: Shaun Morris, The Hospital for Sick Children

An Integrated Toolkit to Save Newborn 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

2294

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kenya
      • Nairobi, Kenya
        • Aga Khan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Neonatal Kit
Mothers in the neonatal kit clusters will receive a neonatal kit and training on how to use the kit components during their third trimester of pregnancy. The 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. Community Health Workers will be equipped with a hand-held battery operated scale to identify low birth weight newborns.
Device: Neonatal Kit

Contents of the neonatal kit:

  1. Clean birth kit: sterile blade, a clean plastic square, plastic gloves, hand soap, and cord ties/clamp.
  2. 4% Chlorhexidine (CHX) lotion (15 mL) and a bag of cotton balls.
  3. Sunflower oil emollient (50 mL)
  4. ThermoSpot
  5. Mylar infant sleeve
  6. Click to heat warmer (http://www.heatinaclick.ca/products/pocket_size.html) in a fitted cloth pouch.
  7. 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.
Experimental: Neonatal Stimulation
During home visits in the 3rd trimester, mothers in the neonatal stimulation clusters will be taught 3 core messages pertaining to neonatal stimulation. First, mothers will be taught how to make eye contact and talk to their child. This type of interaction encourages social inclusion, attachment, and development of social-communication skills. Second, mothers will be taught techniques to foster responsive feeding and caregiving. Finally, mothers will be encouraged to sing songs and nursery rhymes, including those with gentle touch in order to support the development of communication skills, and introduce a tactile component to caregiving. These messages will be reiterated at subsequent home visits by the CHW after the baby is born.
Behavioral: Neonatal Stimulation

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:

  1. Eye contact and talking to children
  2. Responsive feeding and caregiving
  3. Singing songs, including those with gentle touch
Experimental: Neonatal Kit and Neonatal Stimulation
Participants in this arm of the study will receive both a neonatal kit (described in Arm 1) and neonatal stimulation (described in Arm 2).
Device: Neonatal Kit

Contents of the neonatal kit:

  1. Clean birth kit: sterile blade, a clean plastic square, plastic gloves, hand soap, and cord ties/clamp.
  2. 4% Chlorhexidine (CHX) lotion (15 mL) and a bag of cotton balls.
  3. Sunflower oil emollient (50 mL)
  4. ThermoSpot
  5. Mylar infant sleeve
  6. Click to heat warmer (http://www.heatinaclick.ca/products/pocket_size.html) in a fitted cloth pouch.
  7. 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.
Behavioral: Neonatal Stimulation

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:

  1. Eye contact and talking to children
  2. Responsive feeding and caregiving
  3. Singing songs, including those with gentle touch
No Intervention: Control (Standard Care)

In control clusters, CHWs will visit the home according to the regular schedule (same as in the intervention clusters) and deliver the standard CHW post-natal care that consists of talking to mothers about:

  • Exclusive breastfeeding and proper nutrition for both the mother and the baby.
  • Ensuring warmth to the baby.
  • Full immunization and growth monitoring of newborn.
  • Hygiene and sanitation practices.
  • Family Planning and promote the proper use of Insecticides Treated Nets.
  • Identifying any danger sign/complication for both mothers and new-borns and refer for prompt treatment (within 24 hours) for management and treatment.
  • Promoting the use of services such as birth registration.
  • Giving advice on proper care of the umbilical cord.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months of age

Secondary Outcome Measures

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

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

  1. Moderate hypothermia: pale green and red face (35ºC to 36ºC)
  2. Severe hypothermia: black face (<35ºC)
Day 1 (or as soon as possible after notification of birth), 3, 7, 14, and 28 of life
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)
Day 1 (or as soon as possible after notification of birth), 3, 7, 14, and 28 of life
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
Day 1 (or as soon as possible after notification of birth), 3, 7, 14, and 28 of life
Health facility use
Time Frame: Day 1 (or as soon as possible after notification of birth), 3, 7, 14, and 28 of life
Day 1 (or as soon as possible after notification of birth), 3, 7, 14, and 28 of life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hospital for Sick Children

Collaborators

Aga Khan University
Grand Challenges Canada
March of Dimes

Investigators

  • Principal Investigator: Shaun K Morris, MD, MPH, The Hospital For Sick Children
  • Principal Investigator: Robert Armstrong, Aga Khan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

August 1, 2014

First Submitted That Met QC Criteria

August 4, 2014

First Posted (Estimate)

August 5, 2014

Study Record Updates

Last Update Posted (Estimate)

July 14, 2016

Last Update Submitted That Met QC Criteria

July 13, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1000044053

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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