| Methods |
"The 83 infants who participated in the study were randomly assigned to one of three groups". One control group and 2 experimental groups. Iniital demographic data were collected on each infant upon entry into the study. Information included date of birth, gestational age, birth weight and present weight, diagnosis and overall skin condition. The nursing staff kept a record of the date, time and reasons for each tape change, whether base and/or stabilisation layers were changed, and the condition and colour of the skin under the base layer. This information was recorded on a tape change record at the bedside. |
| Participants |
Infants requiring initial oral endotracheal intubation following admission to the NICU were eligible. Infants remained in the study until extubation or death. Infants with a primary diagnosis of respiratory distress regardless of etiology were included. Infants with primary or subsequent diagnoses of congenital anomalies or genetic defects were excluded to avoid difficulties with facial assessment |
| Interventions |
Control group used transparent tape (Dermiclear®) as a base layer (layers on the infant's skin upon which stabilization tapes are placed) and 2 experimental groups were a skin barrier (Hollihesive®) and a hydrocolloid dressing (Duoderm®). The transparent tape (Dermiclear®) was cut into moustache‐shaped strips to fit the infant's upper lip and cheek. The two pectin‐based barriers (Hollihesive® and Duoderm®) were cut into moustache‐shaped strips and sized according to the infant's weight |
| Outcomes |
Episodes of stabilization layer changes, self extubation and lip trauma |
| Notes |
"The validity of prior informed consent of parent(s) undergoing the stress and crisis of premature birth has been questioned. For this reason, informed parental consent to enrol the infant was waived in favour of consent of a patient advocate or ombudsman (in this case the chief resident in the NICU or the NICU charge nurse). The University of Utah Health Sciences Institutional Review Board approved the study and the modification of the consent procedure. Parents were advised of their infant's participation in the study along with any additional appropriate information at the earliest opportunity. Parents were able to withdraw the infant at any time if they desired; one infant was withdrawn." |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Not stated how the random sequence was generated |
| Allocation concealment (selection bias) |
Unclear risk |
Not stated whether the allocation list was concealed |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Treatment could not be blinded due to the nature of the study |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Not stated whether the outcome assessor was blinded |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
All patients were accounted for |
| Selective reporting (reporting bias) |
Unclear risk |
Not stated whether all results were reported |
| Other bias |
Unclear risk |
Not stated whether the groups were treated equally apart from the intervention. The groups were similar at the start of the trial |
