Trial Outcomes & Findings for "Eye Protection After Mydriatic Use for ROP Screening: Impact on Vitals Signs and Pain Scores" (NCT NCT01860534)
NCT ID: NCT01860534
Last Updated: 2016-01-14
Results Overview
At 3 times (pre-mydriasis, 1 hour and 3 hours after Cyclomydril drops), subjects were exposed to ambient lighting for a period of five minutes. This usually entailed removing isolette covers and exposing the patient to the ambient room light. During this time, pain and vital signs were recorded every minute. Heart rate was recorded directly from their cardio-respiratory monitor (Agilent M1106C). The mean of the five recorded values for each variable was used
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
28 participants
Primary outcome timeframe
pre-mydriasis, 1 hour and 3 hours after mydriatic drops
Results posted on
2016-01-14
Participant Flow
July 2011 to september 2012. At the University of Texas medical Branch.
60 neonates were excluded prior to randomization since they did not meet inclusion criteria, refused to participate or other reasons.
Participant milestones
| Measure |
Eye Patch Initially Then no Eye Patch
The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care. Two groups were created to ensure comparison of similar gestational ages at the time of initial and secondary exams as younger neonates are often more ill. This added control was to minimize confounding by age or illness.
|
no Eye Patches Initially Then Eye Patches
The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group B was unpatched for their first ROP exam and patched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care. Two groups were created to ensure comparison of similar gestational ages at the time of initial and secondary exams as younger neonates are often more ill. This added control was to minimize confounding by age or illness.
|
|---|---|---|
|
ROP #1
STARTED
|
14
|
14
|
|
ROP #1
COMPLETED
|
14
|
13
|
|
ROP #1
NOT COMPLETED
|
0
|
1
|
|
ROP #2
STARTED
|
14
|
13
|
|
ROP #2
COMPLETED
|
13
|
13
|
|
ROP #2
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Eye Patch Initially Then no Eye Patch
The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care. Two groups were created to ensure comparison of similar gestational ages at the time of initial and secondary exams as younger neonates are often more ill. This added control was to minimize confounding by age or illness.
|
no Eye Patches Initially Then Eye Patches
The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group B was unpatched for their first ROP exam and patched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care. Two groups were created to ensure comparison of similar gestational ages at the time of initial and secondary exams as younger neonates are often more ill. This added control was to minimize confounding by age or illness.
|
|---|---|---|
|
ROP #1
Needed treatment for ROP
|
0
|
1
|
|
ROP #2
discharged prior to ROP #2
|
1
|
0
|
Baseline Characteristics
"Eye Protection After Mydriatic Use for ROP Screening: Impact on Vitals Signs and Pain Scores"
Baseline characteristics by cohort
| Measure |
Eye Patches Initially Then no Patches
n=14 Participants
The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.
|
no Eye Patches Initially Then Eye Patches
n=14 Participants
The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group B was unpatched for their first ROP exam and patched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
0.54 years
STANDARD_DEVIATION 0.04 • n=5 Participants
|
0.53 years
STANDARD_DEVIATION 0.04 • n=7 Participants
|
0.53 years
STANDARD_DEVIATION 0.04 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
14 participants
n=7 Participants
|
28 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: pre-mydriasis, 1 hour and 3 hours after mydriatic dropsAt 3 times (pre-mydriasis, 1 hour and 3 hours after Cyclomydril drops), subjects were exposed to ambient lighting for a period of five minutes. This usually entailed removing isolette covers and exposing the patient to the ambient room light. During this time, pain and vital signs were recorded every minute. Heart rate was recorded directly from their cardio-respiratory monitor (Agilent M1106C). The mean of the five recorded values for each variable was used
Outcome measures
| Measure |
Eye Patches Covers (ROP #1 and ROP #2)
n=26 Participants
The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam while group B was unpatched for their first ROP exam and unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.
|
no Eye Patches Covers (ROP #1 and ROP #2)
n=26 Participants
The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam while group B was unpatched for their first ROP exam and unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.
|
|---|---|---|
|
Heart Rate
Baseline
|
154 Beats per minutes
Standard Deviation 8
|
154 Beats per minutes
Standard Deviation 12
|
|
Heart Rate
1 hour post dilation
|
152 Beats per minutes
Standard Deviation 8
|
163 Beats per minutes
Standard Deviation 10
|
|
Heart Rate
3 hour post dilation
|
154 Beats per minutes
Standard Deviation 8
|
164 Beats per minutes
Standard Deviation 9
|
SECONDARY outcome
Timeframe: pre-mydriasis, 1 hour and 3 hours after mydriatic dropsAt 3 times (pre-mydriasis, 1 hour and 3 hours after Cyclomydril drops), subjects were exposed to ambient lighting for a period of five minutes. This usually entailed removing isolette covers and exposing the patient to the ambient room light. During this time, pain and vital signs were recorded every minute. Respiratory rate was recorded directly from their cardio-respiratory monitor (Agilent M1106C). The mean of the five recorded values for each variable was used
Outcome measures
| Measure |
Eye Patches Covers (ROP #1 and ROP #2)
n=26 Participants
The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam while group B was unpatched for their first ROP exam and unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.
|
no Eye Patches Covers (ROP #1 and ROP #2)
n=26 Participants
The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam while group B was unpatched for their first ROP exam and unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.
|
|---|---|---|
|
Respiratory Rate
Baseline
|
54 Breaths per minutes
Standard Deviation 13
|
47 Breaths per minutes
Standard Deviation 8
|
|
Respiratory Rate
1 hour post dilation
|
54 Breaths per minutes
Standard Deviation 13
|
52 Breaths per minutes
Standard Deviation 13
|
|
Respiratory Rate
3 hour post dilation
|
55 Breaths per minutes
Standard Deviation 11
|
50 Breaths per minutes
Standard Deviation 10
|
SECONDARY outcome
Timeframe: pre-mydriasis, 1 hour and 3 hours after mydriatic dropsAt 3 times (pre-mydriasis, 1 hour and 3 hours after Cyclomydril drops), subjects were exposed to ambient lighting for a period of five minutes. This usually entailed removing isolette covers and exposing the patient to the ambient room light. During this time, pain and vital signs were recorded every minute. Oxygen percent saturation was recorded directly from their cardio-respiratory monitor (Agilent M1106C). The mean of the five recorded values for each variable was used
Outcome measures
| Measure |
Eye Patches Covers (ROP #1 and ROP #2)
n=26 Participants
The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam while group B was unpatched for their first ROP exam and unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.
|
no Eye Patches Covers (ROP #1 and ROP #2)
n=26 Participants
The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam while group B was unpatched for their first ROP exam and unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.
|
|---|---|---|
|
Oxygen Percent Saturation
Baseline
|
98 percent saturation
Standard Deviation 3
|
98 percent saturation
Standard Deviation 3
|
|
Oxygen Percent Saturation
1 hour post dilation
|
98 percent saturation
Standard Deviation 3
|
98 percent saturation
Standard Deviation 3
|
|
Oxygen Percent Saturation
3 hour post dilation
|
98 percent saturation
Standard Deviation 3
|
98 percent saturation
Standard Deviation 2
|
SECONDARY outcome
Timeframe: pre-mydriasis, 1 hour and 3 hours after mydriatic dropsAt 3 times (pre-mydriasis, 1 hour and 3 hours after Cyclomydril drops), subjects were exposed to ambient lighting for a period of five minutes. This usually entailed removing isolette covers and exposing the patient to the ambient room light. During this time, pain and vital signs were recorded every minute. Pain scores were recorded by direct observation using the Neonatal and Infant Pain Scale (NIPS). The mean of the five recorded values for each variable was used. NIPS scoring consists of 6 measures associated with neonatal or infant pain, each with a range of 0-7 with low scores (0-2) associated with no pain and scores \> to 4 associated with severe pain. Maximum scoring would be 42 for severe pain and minimal being 0 for no pain. The six measures on NIPS include: facial expression, crying, breathing patterns, arm movements, leg movements and state of arousal.
Outcome measures
| Measure |
Eye Patches Covers (ROP #1 and ROP #2)
n=26 Participants
The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam while group B was unpatched for their first ROP exam and unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.
|
no Eye Patches Covers (ROP #1 and ROP #2)
n=26 Participants
The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam while group B was unpatched for their first ROP exam and unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.
|
|---|---|---|
|
Pain
Baseline
|
0.4 units on a scale
Standard Deviation 0.3
|
0.3 units on a scale
Standard Deviation 0.5
|
|
Pain
1 hour post dilation
|
0.1 units on a scale
Standard Deviation 0.2
|
1.1 units on a scale
Standard Deviation 0.7
|
|
Pain
3 hour post dilation
|
0.2 units on a scale
Standard Deviation 0.2
|
1 units on a scale
Standard Deviation 0.6
|
Adverse Events
Eye Patches Covers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
no Eye Patches Covers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Cara Geary
University of Texas medical Branch, Galveston
Phone: 409-772-2815
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place