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Report for Clinical Trial NCT01860534

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

"Eye Protection After Mydriatic Use for ROP Screening: Impact on Vitals Signs and Pain Scores"

Pupillary dilation induced by mydriatic agents during Retinopathy of Prematurity exams can persist for hours. Despite regular use of eye protection for mydriatic-induced light sensitivity for infants, children and adults, eye protection after mydriasis has not been addressed in neonates. This study examines the use of eye patches to protect the dilated pupil from light exposure and their impact on vital signs and pain scores. prevents tachycardia, tachypnea and discomfort in neonates after ROP screening.

NCT01860534 Light Sensitivity
MeSH:Photophobia
HPO:Photophobia

1 Interventions

Name: eye covers

Description: 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.
Type: Behavioral
Group Labels: 1

Eye patches covers


Primary Outcomes

Description: 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

Measure: Heart Rate

Time: pre-mydriasis, 1 hour and 3 hours after mydriatic drops

Secondary Outcomes

Description: 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. Respiratory rate was recorded directly from their cardio-respiratory monitor (Agilent M1106C). The mean of the five recorded values for each variable was used

Measure: Respiratory Rate

Time: pre-mydriasis, 1 hour and 3 hours after mydriatic drops

Description: 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. 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

Measure: Oxygen Percent Saturation

Time: pre-mydriasis, 1 hour and 3 hours after mydriatic drops

Description: 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. 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.

Measure: Pain

Time: pre-mydriasis, 1 hour and 3 hours after mydriatic drops

Purpose: Supportive Care

Allocation: Randomized

Crossover Assignment


There is one SNP

SNPs


1 M1106C

Heart rate was recorded directly from their cardio-respiratory monitor (Agilent M1106C). --- M1106C ---

Respiratory rate was recorded directly from their cardio-respiratory monitor (Agilent M1106C). --- M1106C ---

Oxygen percent saturation was recorded directly from their cardio-respiratory monitor (Agilent M1106C). --- M1106C ---



HPO Nodes


HPO:
HP:0000613: Photophobia
Genes 304
RAX2 CRX DKK1 GUCY2D HGSNAT MBTPS2 DRAM2 RP1 LRAT ERCC4 OCA2 HLA-A RDH12 COL17A1 ATXN7 RPGR FOXC2 IDH3A KLRC4 MITF DDB2 MAK PDE6H CACNA2D4 IFT172 BEST1 CDHR1 POMGNT1 RPGRIP1 ATF6 IL12A MCOLN1 FSCN2 RIMS1 CRX KCNV2 TAT ERCC6 CHST6 PROM1 C8ORF37 BBS2 CRB1 CACNA2D4 PIKFYVE LSS RP9 NR2E3 ARL2BP CABP4 IMPG2 CA4 HADHA RBP3 IL12A-AS1 ATF6 KIZ ERAP1 RGS9 PRPF8 PRPH2 TOPORS GUCA1A PCYT1A XPA RPGR ST14 MFRP HPS6 ABCA4 PRPF4 WNT10A TUB RHO FAM161A NLRP3 PRPH2 TGFBI GUCY2D AP3D1 GUCY2D PITPNM3 TP63 ITM2B CEP250 SAG CEP78 ZNF408 USH2A PRPF6 NOD2 GUCA1A CNGA1 MERTK ERCC3 OPN1MW ANTXR1 OPN1MW POC1B NR2E3 CNNM4 ARHGEF18 KIAA1549 PLCD1 CTNS IDH3B KLHL7 HLA-B PRPF3 SLC7A14 PRPH2 SEMA4A CNGB1 CST6 CDHR1 ERCC2 CHST6 RPE65 ADAM9 MBTPS2 GTF2E2 AGBL5 CFAP410 MEFV TIMM8A ATF6 C4A CNGA3 GNAT2 UBAC2 RDH5 CRX CA4 RLBP1 RPGR MBTPS2 TP63 ITGB6 ALMS1 IL23R SLC45A2 RPGRIP1 EYS CNNM4 SLC1A3 NEK2 PRPH2 FOXC2 KRT12 ALDH3A2 GPR143 PDE6H MCOLN1 CERKL SCAPER PRCD PCARE TYR LTBP2 DHDDS CACNA1F ZNF513 GTF2H5 TARS1 TTLL5 OPN1LW CFAP410 GPR143 RHO PDE6C DDB2 ERCC2 TLR4 GUCA1B GNAT2 GJB2 CNGA3 CNGB3 STAT4 ZNF408 POLH IL10 GJB6 DRAM2 MPLKIP HARS1 UNC119 PDE6C ALMS1 CDHR1 PRPF31 OPN1LW EDNRA CNGA3 MAPT MC1R SLC1A3 ALDH3A2 HLA-B SLC39A4 CRYGC ROM1 C8ORF37 PDE6B TGFBI RNF113A RTN4IP1 LRAT CTNS TYR OVOL2 SLC24A5 PRPH2 PDE6G TYR CLRN1 IKZF1 TTC8 NRL NLRP1 PDE6A SLC6A19 GJB6 RAB28 RGR TYR PCNA RGS9BP PROM1 XPC SEMA4A PRPH2 NMNAT1 XPA ARL6 ERCC2 PCNA ABCA4 GJB6 CNGB3 HK1 TTC8 LYST ERCC5 TULP1 AIPL1 SLC24A5 NMNAT1 RPE65 RAX2 REEP6 XPC OPN1LW SEMA4A AHSG EYS TIMM8A AHI1 LYST RPGRIP1 TACSTD2 SPATA7 GNAT2 SNRNP200 ELOVL1 CACNA1F DHX38 FAS AHR CCR1 CTNS AP1B1 ERCC2 GUCA1A MAPT POLH TNF HLA-DRB1 PDE6C RP2 RLBP1 AIRE PNPLA6 RPGR ESR1 ERCC3 LRMDA GNB3 SCN1A POLA1 IMPDH1 IFT140 PITPNM3 GJB2 FOXE3 OPN1MW TYR CNGB3 ARL3 IFT88 KCNJ13 C8ORF37 AP3B1 OFD1
Protein Mutations 1
M1106C
SNP 0