Clinical Trials Logo
  1. Home
  2. Retinopathy of Prematurity
  3. NCT00845624

Time Outside Target Oxygen Saturation Range in Preterm Infants and Long Term Outcomes and Preterm Infants — SAT01ROP  

Retinopathy of Prematurity Clinical Trial

Official title:
DURATION OF TIME OUTSIDE, BELOW, AND ABOVE THE TARGETED Oxygen SATURATION RANGE In Preterm Infants

Clinical Trial Summary

The purpose of this study is to determine if there is a relationship between time spent out the targeted oxygen saturation range in preterm infants is associated with long-term outcomes such as Retinopathy of Prematurity.

Clinical Trial Description

All infants who had a birth weight of less than 1500 grams or less than 32 weeks gestation admitted to our neonatal intensive care unit (NICU) were eligible for the study. All infants were placed on Nellcor N600 pulsoximetry. Saturation data in two-second sampling from N600 OXIMAX pulse oximeters (Covidian, CA) was collected using a modified Nellcor® Oxinet® III system (Covidian, CA and Cardiopulmonary, Milford, CT) Alarm limits were set at 83% and 93% while infants required oxygen supplementation and 85% to 100% when neonates were in room air. Desaturation events were defined as number of times the saturation fell below the low saturation limit set on the monitor (83% if oxygen requirement >21%, 85% if patient on room air). High saturation events were defined as the number of times the patient's saturation was above the upper saturation limit (93% if oxygen requirement >21%)

The data collection system summarized each day in tabular form including average SPO2, number of low and high SPO2 events, duration of events in minutes, and the percentage of time infants spent outside of the intended saturation range. Primary outcome was threshold ROP requiring laser ablation. Data on ROP was collected during hospitalization and after discharge until resolution of ROP by pediatric ophthalmologist blinded to the study results. Secondary outcomes included bronchopulmonary dysplasia, length of hospitalization, sepsis, focal bowel perforation, necrotizing enterocolitis (stage 2 or greater), patent ductus ligation, intracranial hemorrhage, and number of red blood cell and platelet transfusions. ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00845624
Study type Observational
Source University of Virginia
Contact
Status Completed
Phase N/A
Start date January 2007
Completion date June 2009
View Details
See also
  Status Clinical Trial Phase
Completed NCT05043077 - Efficacy and Safety of Mydriatic Microdrops for Retinopathy Of Prematurity Screening Phase 4
Completed NCT04838665 - Changes in Vital Signs and Pupil Diameter Related to Pharmacologic Mydriasis in Premature Infants: A Randomized Double Blind Clinical Study Phase 4
Completed NCT04408807 - Stress Induced by Screening for Retinopathy of Prematurity - Should Speculum and Indentation Rather be Avoided N/A
Recruiting NCT03083431 - Oral Propranolol for Prevention of Threshold Retinopathy of Prematurity Phase 2
Enrolling by invitation NCT04985448 - Real World Study of the Effectiveness and Safety of Conbercept Ophthalmic Injection in the Treatment of Retinopathy of Prematurity - Multicenter, Retrospective and Observational Study Based on Real World Data
Recruiting NCT02090322 - Bevacizumab 0.500MG Intravitreal There Isn't Lower Than 0.625MG in the Treatment of ROP Type 1 N/A
Completed NCT00872664 - Skin and Serum Carotenoids in Preterm Infants Fed on a Formula Supplemented With Carotenoids N/A
Unknown status NCT00254176 - Cysteine Supplementation in Critically Ill Neonates Phase 2/Phase 3
Completed NCT06452524 - Prematurity and Ophthalmological Changes
Completed NCT04101721 - Study to Assess the Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Compared to Laser Photocoagulation in Patients With Retinopathy of Prematurity Phase 3
Enrolling by invitation NCT02050971 - Autologous Cord Blood Infusion for the Prevention and Treatment of Prematurity Complications In Preterm Neonates Phase 1
Terminated NCT01335113 - A Scan Ultrasonography in the Evaluation of Retinopathy of Prematurity
Active, not recruiting NCT00027222 - The Early Treatment for Retinopathy of Prematurity Study (ETROP) Phase 2/Phase 3
Recruiting NCT06109285 - Validation of i-ROP DL to Detect More Than Mild ROP N/A
Completed NCT01861470 - REDEXAM - Reducing Painful Eye Examinations in Preterm Infants N/A
Completed NCT02014454 - Safety and Efficacy of Propranolol Eye Drops in Treating Retinopathy of Premature Phase 2
Terminated NCT00634972 - Efficient Study of ACULAR in Inhibiting Proliferative Retinopathy in Prematurity Phase 4
Completed NCT05701124 - Intravitreal Ranibizumab Injection for Aggressive Versus Type 1 Prethreshold Retinopathy of Prematurity Phase 3
Completed NCT04092127 - Pain of Premature Babies and RetCam (DOLICAM)
Completed NCT04621136 - PhaseI/II Investigator-Initiated Trial to Investigate Safety and Efficacy of Ripasudil in Patients With Retinopathy of Prematurity Phase 1/Phase 2