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Newborn Kit to Save Lives and Brains in Kenya

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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

Tracking Information
First Submitted Date  ICMJE August 1, 2014
First Posted Date  ICMJE August 5, 2014
Last Update Posted Date July 14, 2016
Study Start Date  ICMJE November 2014
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 16, 2015)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 4, 2014)
Neurodevelopment as measured by the Kilifi Developmental Inventory assessment [ Time Frame: 12 months of age ]
The Kilifi Developmental Inventory (KDI) was designed in Kenya to assess the psychomotor function of children aged 6 to 35 months of age in resource-limited settings. Importantly, the KDI was locally developed and has recently been evaluated at two sites in the Mombasa district, Kilifi and Kisauni, the same districts that will be utilized in this trial. The assessment was deemed to be reliable, valid, contextually acceptable, and capable of identifying children with a developmental delay (Abubakar et al., 2008). The assessment will take place in the child's home in the presence of their primary caregivers. At the assessment, the study worker will explain and demonstrate each new inventory task (the KDI consists of 69 items) before monitoring the child attempt the activity and scoring their abilities. The study worker will be blinded to the arm of the intervention to which the participants were enrolled.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 4, 2014)
  • 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
  • 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)
  • 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.
  • 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)
  • 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)
  • 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
  • Health facility use [ Time Frame: Day 1 (or as soon as possible after notification of birth), 3, 7, 14, and 28 of life ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Newborn Kit to Save Lives and Brains in Kenya
Official Title  ICMJE An Integrated Toolkit to Save Newborn Lives and Brains in Kenya
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Neurodevelopment
  • Neonatal Mortality
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Device: Neonatal Kit
  • 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.
    Intervention: Behavioral: Neonatal Stimulation
  • 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).
    Interventions:
    • Device: Neonatal Kit
    • Behavioral: Neonatal Stimulation
  • 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 13, 2016)
2294
Original Estimated Enrollment  ICMJE
 (submitted: August 4, 2014)
6000
Actual Study Completion Date  ICMJE April 2016
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Kenya
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02208960
Other Study ID Numbers  ICMJE 1000044053
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Shaun Morris, The Hospital for Sick Children
Study Sponsor  ICMJE The Hospital for Sick Children
Collaborators  ICMJE
  • Grand Challenges Canada
  • March of Dimes
  • Aga Khan University
Investigators  ICMJE
Principal Investigator: Shaun K Morris, MD, MPH The Hospital for Sick Children
Principal Investigator: Robert Armstrong Aga Khan University
PRS Account The Hospital for Sick Children
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP