Newborn Kit to Save Lives and Brains in Kenya

NCT02208960 | Completed Phase 3 DMC

• 1 other identifier: 1000044053
• Study Type: interventional
• Target: 2,294
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurodevelopment; Neonatal Mortality

Keywords

Neurodevelopment; Neonatal kit; Kenya; Cluster Randomized Controlled Trial; Chlorhexidine; ThermoSpot

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Neonatal mortality

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

• Incidence of omphalitis

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

• Incidence of severe infection

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

• Cases of hypothermia identified

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

• Cases of hyperthermia identified

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

Study Arms (4)

Neonatal Kit

EXPERIMENTAL

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

Neonatal Stimulation

EXPERIMENTAL

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

Neonatal Kit and Neonatal Stimulation

EXPERIMENTAL

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; Behavioral: Neonatal Stimulation

Control (Standard Care)

NO INTERVENTION

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.

Interventions

Neonatal Kit DEVICE

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.

Neonatal Kit; Neonatal Kit and Neonatal Stimulation

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: 1. Eye contact and talking to children 2. Responsive feeding and caregiving 3. Singing songs, including those with gentle touch

Neonatal Kit and Neonatal Stimulation; Neonatal Stimulation

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• i. Failure to provide consent to enroll in study (intervention or control clusters).

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Grand Challenges Canada: collaborator
• March of Dimes: collaborator
• Aga Khan University: collaborator

Study Sites (1)

Aga Khan University

Nairobi, Kenya

Location

Related Publications (9)

• 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.

  PMID: 18727851 BACKGROUND

• 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.

  PMID: 22579125 BACKGROUND

• 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.

  PMID: 22692417 BACKGROUND

• 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.

  PMID: 22322124 BACKGROUND

• 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.

  PMID: 18310201 BACKGROUND

• 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. doi: 10.1016/S0140-6736(06)68381-5.

  PMID: 16546539 BACKGROUND

• 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.

  PMID: 19845951 BACKGROUND

• 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.

  PMID: 22692418 BACKGROUND

• Pell LG, Bassani DG, Nyaga L, Njagi I, Wanjiku C, Thiruchselvam T, Macharia W, Minhas RS, Kitsao-Wekulo P, Lakhani A, Bhutta ZA, Armstrong R, Morris SK. Effect of provision of an integrated neonatal survival kit and early cognitive stimulation package by community health workers on developmental outcomes of infants in Kwale County, Kenya: study protocol for a cluster randomized trial. BMC Pregnancy Childbirth. 2016 Sep 8;16(1):265. doi: 10.1186/s12884-016-1042-5.

  PMID: 27608978 DERIVED

Study Officials

• Shaun K Morris, MD, MPH

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

• Robert Armstrong

  Aga Khan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Staff Physician

Study Record Dates

• First Submitted: August 1, 2014
• First Posted: August 5, 2014
• Study Start: November 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: July 14, 2016

Record last verified: 2016-07

Locations

KE (1)