Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06265363
Status:
RECRUITING
Last Update Posted:
2024-02-20
First Post:
2024-02-01
Brief Title:
Evaluation of the Frequency Risk Factors and Outcomes of ROP in Infants With a BW 1500 Grs or GA 33 Wks in Turkey
Sponsor:
Baskent University Ankara Hospital
Organization:
Baskent University Ankara Hospital
Study Overview
Official Title:
Evaluation of the Frequency of Retinopathy of Prematurity Influencing Risk Factors and Treatment Outcomes in Premature Infants With a Birth Weight 1500 Grams or Gestational Age 33 Weeks in Turkey TR-BigROP
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TR-BigROP
Brief Summary:
The study includes preterm infants who are being screened for ROP between August 12023 and August 1 2024 in 94 neonatal intensive care units NICUs in Turkey Infants with birth weight BW of 1500 g or 33 weeks gestation who are screened for retinopathy of prematurity are included The incidence of any ROP severe ROP and treatment modalities will be determined The risk factors for ROP development will also be evaluated
Detailed Description:
This study promoted by the Turkish Neonatology Society involved preterm infants who are being screened for ROP between August 12023 and August 1 2024 in level IIIIV Turkish NICUs
An electronic questionnaire is being filled by certified neonatologists in Turkey via a special network Neonatologists working in 94 centers who agreed to participate in this study provide their data regarding the ROP in their NICU The medical records of retinal examinations of preterm infants who met the screening criteria will be evaluated
A case report form for each patient will be filled including risk factors for the development of ROP such as gestational age birth weight small for gestational age SGA gender multiple gestation antenatal steroid therapy invitro fertilization preeclampsiaeclampsia infants of diabetic mother chorioamnionitis resuscitation in delivery room respiratory distress syndrome RDS duration of mechanical ventilation and oxygen therapy intracranial hemorrhage hemodynamically significant patent ductus arteriosus PDA earlylate sepsis necrotising enterocolitis NEC number of blood transfusions bronchopulmonary dysplasia BPD time to full enteral feeding percentage of own mothers milk
Risk factors for developing ROP will be evaluated Multivariate analysis will be performed among significant variables In addition the incidence of any ROP severe ROP in relation to GA and BW and treatment modalities will be determined
Severe ROP is defined as ROP requiring treatment Since Turkey is receiving many refugees in recent years the investigators also planned to evaluate the incidence and risk factors for developing ROP in preterm babies of refugees
Ophthalmologic examination is continued until full vascularisation So the maximum stage of ROP detected for every infant will be reported Data from 94 NICUs will be pooled together and analyzed
The International Classification of ROP guidelines ICROP-3 are used to record the stage of disease location by zone signs of plus disease and signs of regressionreactivationpersistent avascular retina
Criteria for treatment of ROP are based on the Early Treatment for Retinopathy of Prematurity ETROP recommendation
Confirmed forms are also assigned by the parents before the initial screening and treatment
An electronic questionnaire is being filled by certified neonatologists in Turkey via a special network Neonatologists working in 94 centers who agreed to participate in this study provide their data regarding the ROP in their NICU The medical records of retinal examinations of preterm infants who met the screening criteria will be evaluated
A case report form for each patient will be filled including risk factors for the development of ROP such as gestational age birth weight small for gestational age SGA gender multiple gestation antenatal steroid therapy invitro fertilization preeclampsiaeclampsia infants of diabetic mother chorioamnionitis resuscitation in delivery room respiratory distress syndrome RDS duration of mechanical ventilation and oxygen therapy intracranial hemorrhage hemodynamically significant patent ductus arteriosus PDA earlylate sepsis necrotising enterocolitis NEC number of blood transfusions bronchopulmonary dysplasia BPD time to full enteral feeding percentage of own mothers milk
Risk factors for developing ROP will be evaluated Multivariate analysis will be performed among significant variables In addition the incidence of any ROP severe ROP in relation to GA and BW and treatment modalities will be determined
Severe ROP is defined as ROP requiring treatment Since Turkey is receiving many refugees in recent years the investigators also planned to evaluate the incidence and risk factors for developing ROP in preterm babies of refugees
Ophthalmologic examination is continued until full vascularisation So the maximum stage of ROP detected for every infant will be reported Data from 94 NICUs will be pooled together and analyzed
The International Classification of ROP guidelines ICROP-3 are used to record the stage of disease location by zone signs of plus disease and signs of regressionreactivationpersistent avascular retina
Criteria for treatment of ROP are based on the Early Treatment for Retinopathy of Prematurity ETROP recommendation
Confirmed forms are also assigned by the parents before the initial screening and treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None