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Newborn Kit to Save Lives and Brains in Kenya

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02208960
Recruitment Status : Completed
First Posted : August 5, 2014
Last Update Posted : July 14, 2016
Sponsor:
Collaborators:
Grand Challenges Canada
March of Dimes
Aga Khan University
Information provided by (Responsible Party):
Shaun Morris, The Hospital for Sick Children

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Neurodevelopment Neonatal Mortality Device: Neonatal Kit Behavioral: Neonatal Stimulation Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2294 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: An Integrated Toolkit to Save Newborn Lives and Brains in Kenya
Study Start Date : November 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

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.



Primary Outcome Measures :
  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 Outcome Measures :
  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:

    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)

  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:

    1. Moderate hypothermia: pale green and red face (35ºC to 36ºC)
    2. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02208960


Locations
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Kenya
Aga Khan University
Nairobi, Kenya
Sponsors and Collaborators
The Hospital for Sick Children
Grand Challenges Canada
March of Dimes
Aga Khan University
Investigators
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Principal Investigator: Shaun K Morris, MD, MPH The Hospital for Sick Children
Principal Investigator: Robert Armstrong Aga Khan University

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Shaun Morris, Associate Staff Physician, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT02208960    
Other Study ID Numbers: 1000044053
First Posted: August 5, 2014    Key Record Dates
Last Update Posted: July 14, 2016
Last Verified: July 2016
Keywords provided by Shaun Morris, The Hospital for Sick Children:
Neurodevelopment
Neonatal kit
Kenya
Cluster Randomized Controlled Trial
Chlorhexidine
ThermoSpot
Additional relevant MeSH terms:
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Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents