The objective of the study has the intention to prove that a pre-and dysmature baby in a supported back-position, by the use of a controlled moulder, shows more signs of comfort than a specific baby in a freely supine position.We are basing…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
gezonde pre- en dysmature pasgeborenen met een gecorrigeerde leeftijd van 34 weken of minder en een geboortegewicht van - 2.5 SD
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
exposure variable: the measure of the difference in motor -design on the TIMP
-test between 40 babies in a supported moulder position and 40 baby's in a
free back-position
outcome variable: the statistic significance of the possible surplus value of
the positioning of the concerned group of baby's in a moulder
Secondary outcome
parents experience: the well-being in case of this study
'fall-outs': the percentage and its statistic foundation.
Background summary
The 'Guideline Prevention of the Sudden Infant Death Syndrom' , which has been
achieved by the National Government Institution and and the 'Youth Health Care'
( 2009) has determined a statistic significant prove for the reduce of the
number of babies with Sudden Infant Death Syndrom
( SIDS). This measure prescribes , that all neonates, pre- and dysmature babies
included, have to be positioned in a freely supine position .
Besides to that, the advice has been given never to use loose particles and
tools like pillow-and towelnests, side-position pillows and toys in bed, which
has to be ment to support the baby.
After the publishing of the Guidelinde , however, a lot of babies show a lack
of comfort in the freely supine position These expressions of discomfort
manifest themselves as:
- autonomic reactions ( disregulation of heart/ lung , gastro/intestinal and
bloodcirculation )
- motor control ( dysregulation of the patterns, asymmetry and plagiocephaly )
- the 'state' ( a lack of sleep, cry-behaviour )
- awareness ( avoiding contact and a lack of interaction and a high
irritability ) ( consequences for the well-being of the parents, which possible
can lead tot unsafe circumstances between parents and baby .
The result of these reactions is that parents, caregivers and other persons an
organisations who are involved , such as district nurse- services,
children-physiotherapists, Extern Nursing Teams and Video Interaction Teams are
looking for a solution to achieve more comfort for the baby. Sometimes they
make a choice for old alternatives, like a loose towel-roll ( a nest ), a gel
and grainmattress and a side-position pillow. The utilazation of a cradle
-packet has been raised explosively since the Guideline of 2009.In a first view
a cradle-packet offers more comfort to the baby by his deep pressure (
Sensoric Integration ), but it is ineffective to the auto-regulation of the
baby; he's not capable to stay in a tucked ( foetus) position and not capable
to keep his hands near his face .
Study objective
The objective of the study has the intention to prove that a pre-and dysmature
baby in a supported back-position, by the use of a controlled moulder, shows
more signs of comfort than a specific baby in a freely supine position.
We are basing ourselves on the assumption that a two and a half years of
experience with the use of a moulder shows an improved comfort of the baby .
However this positive experience has the need of a statistical prove.
From our information, calimities, such as spontaneously turning to a side -or
prone position of the baby within the moulder, didn't took place.
Evenso cases of emergency and Sudden Infant Death Syndrom didn't occur.
In case of statistic significance ( Evidence Based ) of the more -comfort of
the moulder, there is a need of a further development of this basic system in
cooperation with TNO, because the system of the moulder has to be tested on
safety-factors. The distribution of the moulder is in hands of the hosptitals
and District Care Authourities. In the future probably aterm babies are
considered for promotion to be positioned in a moulder in the first few weeks
after birth .. In this scenario there's a need of a different size..
Study design
Therapeutic Intervention
randomized control trial, open label and intervention caracter
- research group :40 babies in a moulder, supine position and hypotenuse supine
position ( left / right)
- control group: 40 babies in a freely supine position
Primary variable: Test of Infant Motor Performance (TIMP)
parents questionnairy = appendix ( 2 data, 2 identical questionnary's )
Intervention
on behalf of the reasearchgroup : 40 moulders.
Study burden and risks
Presumable, the burden en risks are concerning the control-group : 40
participants in a freely supine positioning ( conform the Guideline Prevention
Sudden Infant Death Syndrom 2009 ) Signs of discomfort* K1
In this case, from ethical reasons, we offer the baby a moulder, as we should
do, originating from the experience in the foreign three years.
The criteria, which are decided seperately or combined :
- > 3 hours a day of crying
- Dysregulation of motor control, persistant asymmetry of posture and
movement, possibly accompanied with plagiocephalie
- bowelcramps and/ or reflux in between the feedings of the baby * (
Resarch Protocol )
- a combination as mentioned above
Albert Schweitzer Plaats 25
Dordrecht 3318 AT
NL
Albert Schweitzer Plaats 25
Dordrecht 3318 AT
NL
Listed location countries
Age
Inclusion criteria
premature baby's <34 weeks
birthweight: <2.5. SD
Exclusion criteria
Congenital defect
syndromal defects
Oxygen- need at home
parents with poor language skills ( questionnaire )
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 | NL40213.101.12 |