Primary Objective: To describe the sleep and arousal patterns of firstborn infants between two and six months of age in day-care compared to home settings during and after the transition from home to day-care. Secondary Objective: To identify…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
nvt
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. infant*s moment of falling asleep
2. infant*s number of times waking up and arousals during sleep
3. infant*s total hours of daytime sleep
4. infant*s moment of waking up
5. parental and day-care staff member*s perception of sleep quality of the
infant
Secondary outcome
1. light intensity during sleep
2. amount of ambient noise during sleep
3. ambient temperature
4. CO2 concentration
5. Nutrition information
Background summary
An increased incidence of cot death at day-care centres compared to child
deaths which occur at home during daytime, both in the Netherlands and in other
countries, is the reason to conduct this study. Data from the Netherlands from
1996 to 2002 showed a relative risk of cot death in day-care of 4.2 compared to
at home deaths (de Jonge et al., 2003). These data added with data up to 2012
showed a somewhat lower, but still increased, relative risk of cot death in
day-care of 2.0 compared to sudden death at home (Voorhout et al.,
2013)(unpublished).
Recent analysis, including cot death children up to 2017, shows a relative risk
of 1.3.
A study from the US showed that about 34% of all cot death cases in day-care
occurred in the first week of day-care (Moon, Patel, & Mcdermott Shaefer,
2000). Because the number of children in the Netherlands attending formal
day-care dramatically increased from 357.000 in 2007 to 467.580 in 2017 (CBS
StatLine, 2018a), it is important to identify factors that contribute to the
increased risk of cot death at day-care.
Study objective
Primary Objective: To describe the sleep and arousal patterns of firstborn
infants between two and six months of age in day-care compared to home
settings during and after the transition from home to day-care.
Secondary Objective: To identify differences between the day-care and the home
environment that may influence sleep and arousal patterns of firstborn infants,
specifically ambient noise, light, temperature, CO2 concentrations and
nutrition information.
Study design
A observational pilot study will be performed to investigate changes in sleep
and arousal patterns of firstborn infants during and after transition from home
to day-care. The infants will be monitored for three weeks: one week at home,
one week both at home and at the day-care during transition from home to the
day-care, and one week both at home and at the day-care. Sleep and arousal
patterns of infants will be monitored via a sensor under the mattress.
Study burden and risks
Risks associated with this study are considered negligible, due to the
observational nature of this study and the non-invasive sleep measurements and
ambient factors measurements (weather station). Filling in the logs, diaries,
and questionnaires are not very time consuming and the burden of filling in
these questionnaires is considered to be minimal. This burden will be evaluated
after the pilot study.
Stippenweg 4
Wageningen 6708 WE
NL
Stippenweg 4
Wageningen 6708 WE
NL
Listed location countries
Age
Inclusion criteria
• The infant is the firstborn child of both parents.
• The infant is between the two and six months of age during transition from
home to day-care.
• The infant is attending day-care at least two days a week, preferably three
days.
Exclusion criteria
• The infant was born prematurely, with a gestational age less than 37 weeks at
birth.
• The infant is part of a multiple birth.
• The infant had a birth weight of less than 2500 g.
• The infant is currently receiving medications that influence sleep patterns
and arousal.
• The infant was exposed in utero to drugs or medications that influence sleep
patterns, i.e. cocaine, methamphetamine, marijuana, benzodiazepines,
antidepressants, antihistamines, or theophylline/caffeine.
• The infant has a diagnosis of brainstem dysfunction, developmental delay,
respiratory system malformations, seizure disorder, congenital cardiovascular
lesions, or hearing impairment.
• The infant is evaluated with or treated for obstructive sleep apnoea or has
craniofacial anomalies associated with obstructive sleep apnoea.
• The infant is swaddled during sleep.
• The household of the infant is multi-problem family and/or excessive
psychosocial problems, according to the GGZ-guidelines, are present in the
household of the infant (Trimbos Institute, 2019).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL68391.081.18 |