Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT00382876 |
| Other study ID # |
LKC-01061958 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
September 29, 2006 |
| Last updated |
October 16, 2006 |
| Start date |
September 2006 |
Study information
| Verified date |
September 2006 |
| Source |
University Medical Centre Ljubljana |
| Contact |
Lilijana Kornhauser Cerar, MD |
| Phone |
+38615226011 |
| Email |
lilijana.kornhauser-cerar[@]guest.arnes.si |
| Is FDA regulated |
No |
| Health authority |
Slovenia: Ministry of Health |
| Study type |
Observational
|
Clinical Trial Summary
The infant car restraint devices are a critical part of infant safety during transportation.
The crash tolerance and the critical safety features of each seat are well established.
Infant transportation may be via a car seat or car bed. The effect of the sitting position
on the airway is a concern in an infant with poor head control. Because of this concern, car
seat tests during which oxygen saturation is measured, are performed on many low birth
weight infants before discharge from the nursery. Indeed, a number of deaths have occurred
in car seats probably related to airway obstruction. The relative effects of position on the
ventilation need to be established.
We propose to identify the relative changes in ventilation that are induced by position
change during sleep. We will collect a broad array of high quality data that will identify
these changes, and the most likely cause. Specifically, we will we screen 200 infants, with
each infant assigned to the supine position, the car bed and the car seat. The order of
these positions will be randomly assigned. Following data will be collected:
1. Relative changes in ventilation will be assessed by oxygen saturation measurement.
2. Respiratory movement will be measured in order to define the defect.
3. Once the data is collected, it will be sent for blind data analysis.
4. Once the data analysis is complete, the effect of position on ventilation will be
established.
Description:
BACKGROUND AND RATIONALE
The safe transportation of infants has formed a critical part of public health policy for
many years. Clearly crash tolerance of the seat, the ease of installation, the position of
the seat and the relative position to airbags has been the focus of intensive research.
However as with all safety devices, there are some limitations. Respiratory instability is a
potential concern due to the upright position in the car seat. This is particularly true in
the premature newborn and has resulted in the recommendation to perform car safety seat
testing before discharge from hospital for these infants.
Recently there have also been concerns raised about term infants. Merchant et al showed that
mean oxygen saturations declined in both term and premature infants reaching a nadir of 95%
after about 70 minutes of placement in a car safety seat with 8% noted to have an SaO2 of
less than 90% for more than 20 minutes. Also, in an earlier study by Bass and Mehta,
selected high risk full term infants were found to have increased risk of developing
hypoxia.
It has been generally accepted that the potential for adverse effects from these hypoxic
events are substantially offset by the crash protection afforded by these devices.
Unfortunately, the portability of car seats and contemporary busy lifestyles are resulting
in infants spending extended periods of time in the car seat for reasons other than
transport. Callahan et al found in 187 infants that 94% spent greater than 30 minutes in
seating devices including car seats each day. The mean time spent in seating devices was
5.7+/- 3.5 hours and ranged from 0 to 16 hours. Prolonged use of car seats in infants too
young to sit unsupported may also potentially result in prolonged periods of oxygen
desaturation.
A recent comprehensive review of peer reviewed published evidence noted that hypoxia has
frequently been associated with significant defects in cognition. In some studies changes in
cognitive function were seen with even mild levels of oxygen desaturation. Such changes were
observed in all groups except premature babies. The young child may be relative resistant,
as their physiology is adapted for the relatively hypoxic intrauterine environment. However
a recent study also suggests that premature infants may also have problems. Thus a cautious
approach has been adopted where children who fail to maintain adequate oxygen saturation
while placed in the car seat are discharged in a car bed.
The cause of the hypoxia while placed in the car safety seat is most likely attributable to
the relative vulnerability of the airway in the premature and term infant. The cause of the
airway narrowing is slouching of the head forward while asleep in car seats which results in
closure of the mouth, the pressing of the tongue against the posterior pharyngeal wall and
the flexion of the airway. The shape of the newborn head with a prominent occiput and the
reduced muscle tone encourages head slouching. A recent pilot study suggested that the
placement of an insert which accommodated the occiput thus reducing the tendency towards
flexion improved airway size and reduced the frequency of episodes of oxygen desaturation.
Thus the flexion position, which is unique to the car seat, may have important implications
for the airway of the newborn.
The American Academy of Pediatrics (AAP) currently recommends that infants with documented
oxygen desaturation in a car seat should be transported in a car bed. Car beds should
overcome the position dependent airway instability. However gastro-esophageal reflux may
also occur in the flat position and this could potentially result in significant apnea. The
purpose of this study was to define if the term infant is at increased risk of apnea and
oxygen desaturation while positioned in a semi-reclined car safety seat when compared to
positioning in a car bed.
METHODS
1. Overview Phase I Identify normal healthy newborns (200 newborns) Phase II Explain to
the family the risk benefit of the study Obtain informed consent Review to see if the
baby conforms to inclusion criteria Review to see if the baby does not meet exclusion
criteria Randomization to supine (car bed) or sitting position (car seat) as the 1st
position Phase III Physiological testing to include oxygen saturation, heart rate,
respiratory plethysmography to monitor chest wall movement.
Phase IV Data for blinded and independent review
Over a period of one year, we propose to study 200 patients. Each infant will be
studied in the supine position (30 minutes), car bed (60 minutes) and car seat (60
minutes). The order of positions will be randomly assigned. This size should be
adequate to identify significant differences.
2. Inclusion Criteria
- Weight greater than 2.8 kg
- Gestation 38-41 weeks
- Normal newborn examinations
- Healthy mother
3. Exclusion Criteria
- Weight greater than 4 kg
- Any abnormality on examination
- Any medications in mother and child (including insulin; vitamins and folic acid
are okay).
- Caesarean section
ORGANIZATION
1. Time Table The study will be performed in the mothers' room (rooming-in). We expect to
recruit at least 1-2 infants/day. We expect to recruit easily 200 as about 5000 healthy
newborns per year are delivered in Maternity Hospital in Ljubljana. Both males and
females will be accrued as they present. The study will be performed in the morning in
order to facilitate discharge planning and maximize time for the baby to interact with
the family.
2. Plans for subject recruitment and consent Newborns will be recruited from our Newborn
Nursery Unit. A thorough explanation of each in-patient study will be provided. An
Institutional Review Board consent form will be reviewed with each parent. A copy of
the signed, witnessed consent form will be given to each parent.
3. Potential risks to participants The potential risks associated with this proposal are
minimal, as the infants will have non-invasive measurement of cardio-respiratory
function.
4. Risk/benefit assessment Information acquired in this study does not have treatment
implications at this time. However, if there are significant desaturation, the
attending pediatrician will be informed.
DATA At the time of inclusion, we will collect basic perinatal data, including pregnancy
complications, descriptors of labor and delivery, use of medications in the perinatal period
(drugs, cigarettes, alcohol and caffeine). We will obtain basic information concerning the
infant (i.e. date of birth, sex, and race) as well as birth weight, length, head
circumference and Apgar scores.
1. Data Collection:
Each infant will be assigned a study number and all data will be labeled with this
number. Each infant will have 4 leads place for cardio-respiratory monitoring. Oxygen
saturation will be measured on the left hand. The study will be performed following
feeding and a diaper change. The child will be placed in the designated position as
determined by study randomization. The control position will be established by placing
the infant face up in a standard hospital crib. The supine position will be established
by placing the infant face up in an Aprica Car Bed. The seated position will be
established using a standard car seat that results in 45 degree angle relative to the
horizontal.
2. Early intervention or termination of the study:
The study nurse will be available at all times during the study. Dr. Lilijana
Kornhauser-Cerar, Dr. Irena Štucin Gantar and Prof. David Neubauer or their designated
substitutes will be available for consultation via cellular phone during the study.
If there is significant desaturation to 85% for longer than 10 seconds, the child shall
be stimulated. If there is persistent desaturation, oxygen will be added. If there is
still persistent desaturation, the study will be terminated.
3. Procedures:
- Quality control procedures for data collection and data entry of data forms.
Quality control measures are essential in any research effort. The quality control
measures shall implement by Prof. Janez Stare, PhD, so as to provide detailed and
unambiguous data collection.
- Back-up procedures. Data files will be backed-up and labeled after each study.
Weekly files will be labeled, dated, and archived. The final data sets will be
permanently archived on CDs.
- Confidentiality. An important component of the data management is protection of
subject confidentiality. We will establish a system whereby no names would be
transmitted to the statistics laboratory. We will design the data forms such that
only an ID number appears as an identifier. In transmission of data we include the
infant's date of birth on each form as verification of the recording of the
correct ID number.
DATA ANALYSIS AT IBMI
- Staff at Institute of Biomedical Informatics at Faculty of Medicine at University of
Ljubljana (Inštitut za biomedicinsko informatiko MF, IBMI) with a wide variety of
investigators both within the Ljubljana University Medical Center and outside Ljubljana
University research community. This group has been a data processing resource center
for multi-center studies since 1973. The IBMI has a staff of 16 with expertise in
computerized data collection and tracking systems, quality control procedures, sleep
and statistical analyses.
- Each trace will be scored for 1. apnea; frequency, duration and type, 2. for time with
oxygen saturation 90-94.9%, 85-89.9%, below 85%; 3. for mean oxygen saturation and
heart rate.
LIMITATIONS
1. At University Medical Centre Ljubljana, we have 5,000 births per year. We should be
able to perform at least 1-2 studies per day. We have limited the study time and will
perform the study in the morning so as not to interfere with discharge planing or
family oriented time. We will make every effort to complete the study in the first
year.
2. This study makes physiological measures when there is no car vibration. We recognize
this limitation but this aspect is being investigated by our collaborators in a smaller
study in Japan.
PUBLICATION Drs. Kornhauser-Cerar, Štucin - Gantar, Neubauer and Kinane will be responsible
for the publication of the results. All results will be submitted to a peer review journal
for consideration.
