Newborn Kit to Save Lives and Brains in Kenya

The Hospital for Sick Children

Status and phase: Completed; Phase 3

Conditions: Neonatal Mortality; Neurodevelopment

Treatments: Behavioral: Neonatal Stimulation; Device: Neonatal Kit

Study type: Interventional

Funder types: Other

Identifiers

NCT02208960

1000044053

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,294 patients

Sex: Female

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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2,294 participants in 4 patient groups

Neonatal Kit

Experimental group

Description:

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.

Treatment:

Device: Neonatal Kit

Neonatal Stimulation

Experimental group

Description:

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.

Treatment:

Behavioral: Neonatal Stimulation

Neonatal Kit and Neonatal Stimulation

Experimental group

Description:

Participants in this arm of the study will receive both a neonatal kit (described in Arm 1) and neonatal stimulation (described in Arm 2).

Treatment:

Device: Neonatal Kit

Behavioral: Neonatal Stimulation

Control (Standard Care)

No Intervention group

Description:

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.