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Report for Clinical Trial NCT00623220

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Randomized Controlled Trial on the Effectiveness of Inhaled Nitrous Oxide for Pain Relief During ROP Screening Exam in the Pre-term Infant

The primary objective of the proposed study is to show that inhaled equimolar mixture of oxygen and nitrous oxide (EMONO) will reduce pain associated with retinal exam in the preterm infant, as compared to the current standard treatment (oral sucrose and topical anaesthesia). The investigators also aim to show that EMONO can be used safely in preterm neonates undergoing retinal exam, and will not result in any increase in apnea, bradycardia, or desaturation in the 24 hours following the exam. Finally, the investigators aim to show that EMONO will keep the infant calm, and make retinal examination easier and less traumatic.

NCT00623220 Retinopathy of Prematurity
MeSH: Retinal Diseases Retinopathy of Prematurity Premature Birth
HPO: Abnormal retinal morphology Premature birth Retinopathy

2 Interventions

Name: N2O

Description: EMONO

Type: Other

A

Name: oxygen

Description: oxygen

Type: Other

B


Primary Outcomes

Measure: The primary objective is to show decrease of pain response in the treatment group as measured by the PIPP (Premature Infant Pain Profile) score

Time: PIPP score before, during and after eye exam

Secondary Outcomes

Measure: Heart and respiratory rate will be monitored using one of our NICU integrated monitors. Continuous pulse oximetry will be performed with a Masimo Radical pulse oximeter.

Time: during 48 hours

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 V29C

Heart and respiratory rate will be monitored using one of our NICU integrated monitors: Draeger Infinity Gamma XL (Draeger Medical Canada Inc, Richmond Hill, ON), or HP Agilent V29C/HP 895 (Hewlett Packard Company, Palo Alto, CA). --- V29C ---



HPO Nodes


HPO:
Abnormal retinal morphology
Genes 1425
IDH3A ZNF408 MGMT AP3D1 RNASEH1 CABP4 WDR34 RHO PCARE ATP6 TRIM37 RP1 CNGB3 RDH5 PORCN CTC1 PIGL ATF6 MITF PRSS56 RAX2 LZTFL1 TTC8 PROM1 NMNAT1 TET2 SDCCAG8 FGFR1 C8ORF37 LRAT SALL1 RMRP MYO5A WDPCP PDE6H USH1G PCARE COL4A1 CACNA1F HK1 GABRA2 AP5Z1 SLC25A11 BBS4 PLK4 BAP1 COQ2 DAG1 YWHAG HMCN1 CFHR1 C2CD3 LRP5 PNPLA6 NSMCE2 ARL6 MIR140 RDH12 TRPM1 FZD4 NGLY1 RBP3 IFT172 PAX6 ARL3 PMM2 SCN3A GCK TTC21B NDP PDE6G COL2A1 ENPP1 CFI CACNA2D4 HSD11B2 PRPH2 FBN1 ACTG1 SEMA4A WDR19 SUMF1 ARL2BP GABRG2 SDHA ASXL1 PRPF31 SALL4 MKS1 TUBB4B GUCA1A POMT2 RRM2B NPHP4 TRNL1 POC1B CEP290 COX8A BLK UNC119 LRAT GUCY2D KIAA0586 WDR19 ERCC5 PITPNM3 HIRA SLC19A2 OFD1 BBS5 POMGNT2 LARGE1 COL11A1 PUF60 TRNF ARSG CEP290 NDUFA9 PEX5 MSTO1 EP300 COL11A1 OPA1 COX14 GNA11 PRPH2 ACD RPGRIP1 CERKL MYOC ESS2 GUCA1B CFH PTPN22 SMPD1 PNPLA6 COL2A1 PDE6C TULP1 MFSD8 TINF2 HLA-DPB1 NDUFS1 PET100 CTSA KIF11 PEX5 CFAP410 RHO IL10 IMPDH1 NOTCH3 YAP1 ARVCF GRK1 PRPF8 B3GLCT DGCR6 TMEM237 COL4A1 POMGNT1 NDUFAF2 TMEM127 B9D2 COL2A1 RNF113A CRB1 IFNG PRCD PEX13 IFT27 SDHA MAB21L1 CHST14 PEX12 JMJD1C ACTB GNAT1 FKTN CEP41 ND5 CNGB3 APC MTTP CTSD TMEM138 GRN COL9A3 HPS5 CWC27 HSPD1 GMPPB CFAP410 SDHAF1 GTF2I HADHA KIAA0586 ATP6V0A2 HSD11B2 COA8 POMK PEX2 PRPF6 MCOLN1 PRPF6 ZNF408 ACVRL1 MPLKIP PAX6 PROM1 CIB2 RAX2 INPP5E PNPLA6 COL18A1 FOXE3 DHX38 RP2 PRPH2 BCS1L BEST1 RNU4ATAC SLC52A3 ND4 CLRN1 SDHA TPP1 PAX6 GRK1 VHL ND1 BBS7 PROM1 EFEMP1 KCNV2 CACNA1B TRNE PEX10 NPHP1 CCNQ CHD7 PNPLA6 PCYT1A C8ORF37 B3GALNT2 PEX10 FLNB TULP1 LETM1 APOE RBP3 NDUFAF5 SMPD1 CNGA3 PANK2 NDUFB8 TMEM107 OCA2 FKRP POMT2 PEX11B SDHD RAI1 INVS CEP41 TRAK1 ABCA4 CHST6 MAK ELOVL4 SYNGAP1 KLHL7 POT1 SRD5A3 GATA3 CC2D2A SDHB COX15 TTC8 COL1A1 ERCC5 WWOX TTLL5 FAM161A GABRB2 NRL KRIT1 HPS4 BBS10 KCNA2 CLRN1 PCYT1A TRPM1 NDUFA12 DGCR8 RPGR OTX2 WDR60 LARGE1 MKKS FBN2 BBS5 PEX10 SLC52A2 SDHD HLA-DRB1 COX3 STN1 CNGB3 PDE6B POMT1 GUCY2D GTF2E2 UBE3B PCDH15 TOPORS NUS1 COL2A1 RIMS1 FGF12 HLA-B MAFB ROM1 COX2 CRB1 MTFMT APC CRB1 BBS12 EEF1A2 IFT140 ERCC2 KIZ CDH23 CNGA1 NTRK2 HADHA PCYT1A PEX11B GDNF POLG ACTB ACVRL1 PTEN TNFRSF11A IFT140 NDP FOXRED1 VHL ATP6 CLTC USH2A ABCC6 NOD2 RB1 ERCC6 POGZ IFT172 BCOR ND6 SYNJ1 BEST1 LRP5 RPGR LRIT3 CSPP1 ATXN2 COL5A2 PHYH USP45 DHDDS MIR204 FRG1 RB1 EPG5 CCR1 ERCC2 SCN8A RHO KCNA2 SLC25A15 POU3F4 PDE6B SLC7A14 RFC2 CA4 GRM6 RS1 NDUFS3 HADHB PIK3CA EDN3 CLDN19 TRNT1 PAX6 SLC38A8 SUMF1 OFD1 SLC37A4 HLA-A TBC1D20 CYSLTR2 CRB1 NDUFS4 TRNQ NDP TYR CEP164 PIGL ADAMTSL4 MTTP SLC24A1 TRNN IDS DRAM2 ALG12 CCM2 ATXN7 GDF6 PRPS1 AIPL1 SMCHD1 RLBP1 NSD2 XYLT2 CDK4 PEX6 PAX6 FOXC1 PEX3 ZNF408 ERCC3 AHR KRT25 RET LYST TUBGCP6 RDH12 LZTFL1 PEX14 TMEM98 USH1C NSMCE2 HLA-DPA1 MAPKAPK3 PRPH2 TUBB CEP290 CLN6 MYD88 IDUA PDZD7 DNM1 GNB5 DPM1 CEP290 CEP55 PANK2 PTEN KIF11 B4GAT1 GRM6 CEP83 TMCO1 PRPF4 ATP6 BBS2 GCK ELN FSCN2 MAX NF2 PPP2R3C HADHA MKS1 BBS2 SOX10 MICOS13 ADAM9 PRPF3 IKBKG HCCS TMEM67 PRPF31 IDH3B ETHE1 RPGRIP1 CACNA1F NMNAT1 CRX ELN IL23R VPS13B HCCS TUBGCP4 ND4L CST3 BEST1 ND6 CERKL CLRN1 MC1R ARL6 TOPORS IFT140 CRB1 USH1C DLST VPS13B ATP8 TYR UFD1 GUCA1A SDHB MAF CC2D2A TMEM67 IMPDH1 HNF1A CDH3 SLC13A5 WDPCP FLVCR1 AKT1 ZNF469 CLRN1 KLHL7 ND3 SDHAF2 NPHP3 COL2A1 INS TSC2 ATP6V1A GGCX AP3B2 LRP2 CENPF HGSNAT ANO10 PEX13 ERAP1 RPE65 MC1R CEP290 C8ORF37 ACTA2 TMEM231 GNAQ ARV1 TTC8 PEX12 OPN1MW RHO CHM TERT CACNA1F ARHGEF18 TCTN2 CRX SDHC CRPPA GSS TXN2 CYP4V2 ADAR KLHL7 ALDH1A3 G6PC NRL SPG11 CC2D2A SCN1A TTC8 ALMS1 AIPL1 PDX1 B9D1 PEX5 ERCC3 BBIP1 PEX11B CTLA4 RPE65 ATXN7 FTL IDUA CRPPA TRNS1 PDE6C RBP4 AHI1 AIRE TFAP2A MFRP HCN1 GNAT2 TMEM98 AGBL5 SDCCAG8 C12ORF57 COX7B CNNM4 DHX38 CCND1 CEL RAB28 KIF5A TTLL5 SAG ARL6 POMT1 COX3 TMEM216 CBS PRRT2 TINF2 SIX6 MITF PEX16 ND1 CNNM4 FKRP TTC21B C8ORF37 IFT27 SEMA4A GABRA5 AHI1 PRPF3 OCRL POMT1 GPR179 CNGB1 COL9A2 RAB3GAP1 HNF4A PEX14 BBS1 PDE6B PEX2 SDHA TMEM127 PEX1 TRNK TIMP3 NPHP1 WDR19 FKTN ADAMTSL1 POMGNT1 PEX2 UBAC2 POMGNT1 AHR KIZ RAB3GAP2 RNU4ATAC COL2A1 IMPG1 WDR19 SDHB APPL1 FLII CRB1 C4A FKRP BEST1 PDCD10 ND2 RLBP1 PTEN PROM1 CTNNA1 CNKSR2 SPATA7 CTNNB1 IQCB1 PRPH2 MERTK PIEZO2 RXYLT1 PET100 CTNS WRN PDZD7 CLN5 POMT2 MEFV CACNA1A ZNF423 CASK CFH PDE6G ATP6V1A ERCC8 KIF1B SAG FAM161A MVK RB1 TRNT1 MYO6 MMACHC SYCE1 CSPP1 TUB SLC35A2 SELENOI PEX1 PDE6A OPN1MW TEK GTF2H5 AMACR ND5 SEMA4A PEX1 HMX1 COX3 PAX6 ATP6 TMEM67 BCOR RPGR VCAN ALDH3A2 COX15 ND5 ERCC4 RPGRIP1 RAI1 ZNF513 CDKN2B PARS2 BEST1 REEP6 IQSEC2 ABCA4 RHO CA4 PEX12 TMEM67 FAM111A GNPTAB SBDS ND2 WWOX CEP290 PROM1 SNRNP200 COL2A1 SURF1 PGAP1 IFT172 ADGRV1 EYS TBX1 TMEM231 SLC19A3 DPP6 MMACHC RPGRIP1L UBA5 PRPF4 FOXE3 PEX19 CRX BAP1 GNAT2 SURF1 TENM3 RP1 WT1 LRP5 PLOD1 FDXR CACNA2D4 BCS1L CACNA1F NR2E3 KRT74 COX6B1 ATP6V1E1 GDF3 FLVCR1 SLC24A1 ND2 PRCD RLBP1 SDHA HEXB RDH11 RPE65 KLF11 INPP5E GCDH RPGRIP1L FKRP C12ORF57 SURF1 PNPLA6 POMT2 DGCR2 OPN1LW IQCB1 IL12B PLOD1 BMP4 PORCN ASAH1 INPP5E CTSA DHDDS SDHD PRPH2 MLXIPL ATF6 NMNAT1 CLIP2 C1QTNF5 LAMA1 HLA-B IFT140 RD3 NDUFS2 OPN1MW RP2 REEP6 PROM1 RNF216 FLCN LARGE1 BAP1 PRSS56 SH2B1 PRDM5 CEP290 CNGA1 WWOX NDP TYR PGK1 NDUFS2 TMEM107 SDCCAG8 TRAPPC9 CLN3 IFT172 CFHR3 COL5A1 PDE6G TMEM216 TBL2 MAK ALMS1 COX20 KRT71 PRPH2 ND5 STXBP1 BEST1 COX1 CSPP1 IL12A-AS1 AP3B2 TSC1 GUCA1B FKTN SEC24C ND4L FH ATP6 IDUA HSD17B10 PPT1 DNAJC21 BEST1 PEX26 HACE1 CDKN2A KIAA1549 GUCA1A MAPRE2 OPN1LW PDE6D ARV1 B4GAT1 TUBB OAT CLCN2 CNGA3 COMT SAR1B MKS1 PEX2 NAA10 SACS NF2 MKKS GDF3 SMPD1 KCNJ13 HEXA IFT122 CAPN5 TBX22 RIMS1 TNFRSF11B SERPINC1 GALNT3 PEX14 HFE TRNH PEX10 NEU1 PEX6 CRX USP45 BBS10 COL9A1 CHN1 GNAQ HADHA TRNL1 GBA BBS1 HBB SLC25A15 ERCC2 XRCC4 TUB MKS1 CP PEX13 USH2A DRAM2 OPN1LW GP1BB POLR3A COG1 POMT2 RP9 KRIT1 BCOR BCOR SMAD4 TACO1 MYOC PRF1 WRN SEMA3E NHS PDE6A SDCCAG8 RBP3 OAT TP53 ND1 PAX4 COL2A1 EYS SLC24A5 VHL FASTKD2 NEK1 TRNS1 LTBP2 TYR RPGRIP1 TK2 NPHP1 NYX PEX1 RAX2 B3GALNT2 SDHAF1 IMPDH1 NDP RPGRIP1L TERT RPGR BEST1 CRX TMEM231 RP1L1 FKTN TULP1 FBLN5 COL4A1 LIPH APOC2 PTPN22 COX1 AIPL1 ELOVL4 PEX26 ZEB2 VHL CEP120 CAV1 ASAH1 PEX19 AHI1 ACO2 SAG NDUFA13 SPATA7 CLDN19 ISCA1 COL11A1 PEX12 RPGR TRNW RREB1 TTPA PEPD RNU4ATAC RBP4 ABCA4 POMK GNAT1 MYO7A TSC2 KLRC4 KIF1B CCDC22 IMPG2 SCO1 POMT1 RET PANK2 LCA5 PCDH15 IFT74 FGF3 ARL6 TRIM32 PLK4 ERCC1 PRPH2 PHYH POGZ IFT80 SLC45A2 COX10 HHAT RD3 COX10 DYNC2H1 GZF1 NDUFB11 ROM1 RPE65 TMEM216 IGFBP7 WARS2 PAX2 XYLT2 RGR CREBBP TREX1 PRTN3 GMPPB ATF6 XYLT1 OFD1 PMPCA ETHE1 ND4 PRDX1 GUCY2D SNRNP200 RCBTB1 BBS2 BBS9 ABCA4 CNGB3 GUCY2D ERCC6 HACE1 GUCA1A ZFYVE26 TMEM67 LOXL3 BAZ1B NDUFA4 PEX7 NPHP4 IMPG2 TRNW COA8 ECHS1 FLNB ND6 CACNA1F CACNA1F MPDZ GM2A ABCC8 INS IFT88 ABCC8 RGR ARL13B TARS1 ERCC3 TRNV RPGR CHM ND4 POMGNT1 NEU1 NEK2 LRIT3 WASHC5 IQCB1 DACT1 NDUFAF3 POMGNT2 RNF216 PRPH2 RLBP1 EDNRB COL4A1 RHO SCAPER RLBP1 TACO1 ATOH7 BBS9 SLC19A2 SACS COL2A1 DAG1 RPGR ABCA4 TBX1 C8ORF37 NEUROD1 TEAD1 GTF2IRD1 FAS RAI1 TMEM107 ARL3 NECAP1 SALL4 PEX16 PANK2 ANK1 PRPH2 POMGNT1 CC2D2A KRAS NDUFS7 IFT140 P3H2 PITPNM3 CHEK2 MFSD8 ZFYVE26 RNF113A ADAMTS18 PMM2 PEX7 ABCC6 TERF2IP COL18A1 FZD4 BMP4 CEP78 MDH2 MKS1 CABP4 TRNK FKRP ENG LARGE1 CTNS PEX3 POC1B CYFIP2 GRIN2D HPS6 CDHR1 CRYAB CDHR1 JAG1 PROS1 DEAF1 DUX4 TSC1 IMPG1 NDUFS2 TRIM44 KCNJ13 WDR34 TRIM32 FGFR2 ELMO2 ABHD12 ALDH3A2 GDF6 PEX26 LRP5 ROM1 RRM2B COL11A1 CTNNB1 COL25A1 KCNJ11 CYTB AIPL1 NAA10 EXOSC2 SDHD MAX SLC1A2 ITM2B MITF PEX6 ZNF423 LRAT WFS1 TRAF3IP1 CEP120 ND6 IL12A COL2A1 ARL2BP PDHA1 AP5Z1 PEX26 RXYLT1 HGSNAT PRPS1 APOE CNGA1 EXOSC3 NCAPG2 CEP164 BBS2 CLCNKB RAB18 GPR143 RAB28 RPS6KA3 PEX3 SHH CYTB BBS12 IFT172 TMEM138 LRP2 USH2A GDF2 KCNJ11 GUCY2D STAT3 ABCA4 C8ORF37 AKT1 NDUFA2 AARS1 DHDDS TREX1 LRAT CTNS COL4A1 NR2E3 LMNA PDX1 ADAM9 PRPH2 SMCHD1 PEX1 SCAPER ARL6 SEMA4A SLC12A6 IDH3B PEX5 RTTN INPP5E CYP1B1 TNFRSF11B NDUFAF6 PAX2 APOB ABCA4 ARL6IP6 PEX2 FAM111A NDE1 FBN1 ZNF513 SLC24A5 ND4 TRNS2 TXN2 TMEM67 CEP290 STUB1 RP9 NOD2 GNB3 NELFA NDUFA10 NDUFV2 CFAP410 RDH5 XYLT2 NR2E3 SAG DNM2 LIMK1 TERC NDUFV1 DYNC2LI1 BBS7 NDUFAF1 POMT1 PEX1 MDH2 CCDC28B BBIP1 PTCH1 FAS FRG1 TRNL1 CACNA1A WDR19 CDH3 TULP1 WHRN MCOLN1 AGXT TMEM231 PGK1 ND1 MFRP LIPT1 TLR4 SF3B1 ACOX1 STAT4 GNAT1 SLC45A2 NEK2 PAX6 PEX16 COL9A2 KLHL7 IMPG2 CACNA2D4 SCO2 GGCX IMPG2 PPP3CA LPAR6 ARMC9 LPL NDUFA9 NEK1 ATP1A2 PROM1 TRAF3IP1 HADH LOXL1 TRNL1 TSPAN12 PDE6H SH3BP2 PEX16 PEX6 POMK PEX7 SZT2 TUBGCP6 MYO5A COX7B GPR179 ACTL6B SEMA3E GLB1 BLOC1S3 GPIHBP1 ABCC6 PEX19 NYX SALL1 HADHB GUCY2D PDE6B CHD7 MERTK NDUFB11 BBS4 PDE6C SLC7A14 KCNB1 CHRDL1 MAN2B1 CDHR1 MSTO1 ARHGEF18 RS1 GGCX CDH3 COL11A1 RDH12 CP TBX1 FSCN2 CYP1B1 TUBGCP4 PRPF8 IKBKG CDH3 RPGRIP1 NDUFS8 HGSNAT CNGB1 MLX
Premature birth
Genes 141
CYP11A1 COL5A2 WDR73 AIMP1 NUP107 TDGF1 IGHMBP2 FLVCR2 TP53RK ARHGAP31 DHPS PEX14 PTH1R PEX2 PEX10 MED12 GAS1 FLNB PEX1 TMEM70 MYH7 TGIF1 CDON PEX13 DLL1 RNU4ATAC NEB PNPO GBA NOTCH1 PEX12 CRKL DHCR7 KMT2A LAGE3 ZIC2 DOCK6 ATP8B1 HYLS1 SIX3 TPRKB CLCNKB ZMPSTE24 RNU4ATAC BRAF NODAL PEX19 FZD4 SMC3 FGF8 NLRP3 ZMPSTE24 CRB2 LRP5 FBN1 DISP1 MAP2K2 PEX3 PEX11B KRAS RPS19 TRIP4 SETD5 KLHL41 NDUFB11 WDR4 ACTA1 ADAMTS2 NIPBL ABCA12 SHH SMC1A HOXD13 COL1A1 KLHL40 KCNJ1 RPL10 FGFR1 BRAF COL1A2 KIF7 BSND RAD21 EOGT PEX16 MAPK1 OSGEP CLCNKA NDUFB3 LMNA GLI2 SLC12A1 PTCH1 CYP11A1 TSHR LMOD3 PEX26 RBPJ MAP2K1 STRADA ESCO2 PEX5 SF3B4 PEX6 SLC27A4 COL5A1 MUSK COL1A1 LMOD3 PLEC MAGED2 TPM3 NEB SLC17A5 NUP133 HDAC8 HRAS LMNA COL11A1 ALB NLRC4 BCR CLCN7 ABCB4 KLHL41 SARS2 ITGB4 FLI1 PNPO PTH1R DLL4 NDP ASCC1 FOXH1 COL5A1 SLC26A3 ACTA1 COL3A1 SUFU COL3A1 FIG4
Retinopathy
Genes 123
PHYH KCNJ11 HNF1A STAT3 MGMT CCR1 ALDH3A2 HFE CTNS ABCC8 INS NEU1 ERCC4 MCOLN1 PDX1 ABCC8 COL2A1 CDKN2B INS FGFR1 NDUFAF3 ERAP1 HADHA GNPTAB MYO5A HBB TMEM231 AP5Z1 MKS1 TNFRSF11B PLK4 BAP1 NEUROD1 MMACHC TRNE TMEM107 TXN2 NOD2 KRAS TXN2 GCK NELFA ENPP1 PLOD1 PAX4 NSD2 CDK4 LETM1 APOE PDX1 PANK2 NDUFB8 PEX7 ERCC3 TMEM107 TERF2IP CTLA4 NDUFAF1 CEP41 ASXL1 POT1 PTCH1 FAS KLF11 TERT TRNK TRNL1 SURF1 CTNS HLA-DPA1 BLK AGXT IL12B TUBB TLR4 PTPN22 CEL ERCC5 IDUA STAT4 DPM1 PROS1 C1QTNF5 HLA-B TINF2 KLHL7 COL11A1 SCO2 GCK ACD HNF4A NDUFS2 TULP1 MFSD8 HLA-DPB1 KIF11 KCNJ11 KLRC4 IL10 UBAC2 HLA-B MITF APPL1 C4A CSPP1 IL12A-AS1 IL12A TRIM32 IL23R ERCC2 AP5Z1 ATP6 ABCC6 MEFV CDKN2A MAPRE2 MC1R CDH3 TREX1 PRTN3 MTTP SAR1B MLX