Newborn Kit to Save Lives and Brains in Kenya

Neonatal Mortality Clinical Trial

Official title:

An Integrated Toolkit to Save Newborn Lives and Brains in Kenya

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02208960
• Other study ID #: 1000044053
• Status: Completed
• Phase: Phase 3
• First received: August 1, 2014
• Last updated: July 13, 2016
• Start date: November 2014
• Est. completion date: April 2016

Study information

• Verified date: July 2016
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Institutional Review BoardKenya: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2294
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Neonatal Mortality
• Neurodevelopment

Intervention

Device:
• Neonatal Kit
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.

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

Locations

Country	Name	City	State
Kenya	Aga Khan University	Nairobi

Sponsors (4)

Lead Sponsor	Collaborator
The Hospital for Sick Children	Aga Khan University, Grand Challenges Canada, March of Dimes

Country where clinical trial is conducted

Kenya, 

References & Publications (8)

Abubakar A, Holding P, van Baar A, Newton CR, van de Vijver FJ. Monitoring psychomotor development in a resource-limited setting: an evaluation of the Kilifi Developmental Inventory. Ann Trop Paediatr. 2008 Sep;28(3):217-26. doi: 10.1179/146532808X335679. — View Citation

Arifeen SE, Mullany LC, Shah R, Mannan I, Rahman SM, Talukder MR, Begum N, Al-Kabir A, Darmstadt GL, Santosham M, Black RE, Baqui AH. The effect of cord cleansing with chlorhexidine on neonatal mortality in rural Bangladesh: a community-based, cluster-randomised trial. Lancet. 2012 Mar 17;379(9820):1022-8. doi: 10.1016/S0140-6736(11)61848-5. Epub 2012 Feb 8. — View Citation

Darmstadt GL, Saha SK, Ahmed AS, Ahmed S, Chowdhury MA, Law PA, Rosenberg RE, Black RE, Santosham M. Effect of skin barrier therapy on neonatal mortality rates in preterm infants in Bangladesh: a randomized, controlled, clinical trial. Pediatrics. 2008 Mar;121(3):522-9. doi: 10.1542/peds.2007-0213. — View Citation

Khan A, Kinney MV, Hazir T, Hafeez A, Wall SN, Ali N, Lawn JE, Badar A, Khan AA, Uzma Q, Bhutta ZA; Pakistan Newborn Change and Future Analysis Group. Newborn survival in Pakistan: a decade of change and future implications. Health Policy Plan. 2012 Jul;27 Suppl 3:iii72-87. doi: 10.1093/heapol/czs047. — View Citation

Lawn JE, Kinney MV, Black RE, Pitt C, Cousens S, Kerber K, Corbett E, Moran AC, Morrissey CS, Oestergaard MZ. Newborn survival: a multi-country analysis of a decade of change. Health Policy Plan. 2012 Jul;27 Suppl 3:iii6-28. doi: 10.1093/heapol/czs053. Erratum in: Health Policy Plan. 2013 Oct;28(7):786-8. — View Citation

Liu L, Johnson HL, Cousens S, Perin J, Scott S, Lawn JE, Rudan I, Campbell H, Cibulskis R, Li M, Mathers C, Black RE; Child Health Epidemiology Reference Group of WHO and UNICEF. Global, regional, and national causes of child mortality: an updated systematic analysis for 2010 with time trends since 2000. Lancet. 2012 Jun 9;379(9832):2151-61. doi: 10.1016/S0140-6736(12)60560-1. Epub 2012 May 11. Erratum in: Lancet. 2012 Oct 13;380(9850):1308. — View Citation

Mullany LC, Darmstadt GL, Khatry SK, Katz J, LeClerq SC, Shrestha S, Adhikari R, Tielsch JM. Topical applications of chlorhexidine to the umbilical cord for prevention of omphalitis and neonatal mortality in southern Nepal: a community-based, cluster-randomised trial. Lancet. 2006 Mar 18;367(9514):910-8. — View Citation

Mullany LC, El Arifeen S, Winch PJ, Shah R, Mannan I, Rahman SM, Rahman MR, Darmstadt GL, Ahmed S, Santosham M, Black RE, Baqui AH. Impact of 4.0% chlorhexidine cleansing of the umbilical cord on mortality and omphalitis among newborns of Sylhet, Bangladesh: design of a community-based cluster randomized trial. BMC Pediatr. 2009 Oct 21;9:67. doi: 10.1186/1471-2431-9-67. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neurodevelopment as measured by the Protocol for Child Monitoring - Infant and Toddler version assessment	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	No
Secondary	Neonatal mortality	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	No
Secondary	Incidence of omphalitis	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)	Day 1 (or as soon as possible after notification of birth), 3, 7, 14, and 28 of life	No
Secondary	Incidence of severe infection	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	No
Secondary	Cases of hypothermia identified	Defined using ThermoSpot as: Moderate hypothermia: pale green and red face (35ºC to 36ºC); Severe hypothermia: black face (<35ºC)	Day 1 (or as soon as possible after notification of birth), 3, 7, 14, and 28 of life	No
Secondary	Cases of hyperthermia identified	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	No
Secondary	Number of LBW babies identified	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	No
Secondary	Health facility use		Day 1 (or as soon as possible after notification of birth), 3, 7, 14, and 28 of life	No