None listed
Conditions
Brief summary
Retinopathy of Prematurity (ROP) is the abnormal development of blood vessels in the eye. ROP can occur in premature babies, mainly affecting those born before 31 weeks gestation or with a birthweight under 1300 grams. Not all of these babies will be affected but all at risk babies are routinely checked by an ophthalmologist whilst still in the neonatal unit. The retina lines the inside of the eye. It receives rays of light and sends images to the brain where they are converted into what we see. As the eye develops, tiny blood vessels grow throughout the retina. The blood vessels start developing at 16 weeks of pregnancy and complete growing approximately one month after birth. With ROP, these blood vessels may grow in the wrong direction or stop growing too early. The blood vessels are very fragile and there is a high risk of blood leaking from them. This bleeding can result in scarring and damage to the retina. If there are abnormal blood vessels they can be effectively treated with lasers which is why screening is so important. Baby’s eyes will be examined by a specialist eye doctor known as an ophthalmologist. In order for the ophthalmologist to be able to properly examine the retina, eye drops are needed to enlarge the pupils. These drops are given approximately one hour before the screening. The screening for ROP can result in some babies showing signs of stress. There is also some evidence that ROP screening can cause disruption to a baby’s ability to handle feeds for a short period and may make them more vulnerable to developing infections related to the gastrointestinal tract. For this reason, feeding is paused at the time of screening. This study aims to better understand the underlying changes that lead to these effects and determine whether they are related to changes in blood flow to the gastrointestinal tract. This study further seeks to identify during which stage of the ROP screening process these changes occur and whether it is related to the eye drops used in the screening process. The early detection of ROP is vital in protecting the future vision of premature neonates. This study aims to contribute to ensuring that the screening process is as safe as possible. This study measure physiological parameters (heart rate, blood pressure, pulse oximetry) as well as regional oxygenation using near-infrared spectroscopy and coeliac ultrasound dopplers.. These measurements are taken before, during, and for 3 hours after screening.
Interventions
Inclusion and exclusion criteria:
Infants will be considered for recruitment into the study if they meet the criteria for screening for ROP
Study methods:
This is an observational study. The decision to screen a neonate for retinopathy of prematurity is based on evidence-based local guidelines.
Informed parental consent will be obtained in all cases prior to data collection.
Once the parental consent is obtained, following data will be collected as part of this study:
Patient characterist
Inclusion and exclusion criteria: Infants will be considered for recruitment into the study if they meet the criteria for screening for ROP Study methods: This is an observational study. The decision to screen a neonate for retinopathy of prematurity is based on evidence-based local guidelines. Informed parental consent will be obtained in all cases prior to data collection. Once the parental consent is obtained, following data will be collected as part of this study: Patient characteristics: • Gestational age • Postnatal age • Ethnicity • Sex • Birth weight (customized centile) • Weight at time of ROP screening • Respiratory support required at time of examination • Caffeine treatment Cerebral and gastrointestinal (splanchnic) oxygenation levels will be measured for 1hrs pre-, during and for 3 hours post Retinopathy of Prematurity screening. Multi-site NIRS system (Nonin SenSmartTM Model X-100) with non-adhesive regional oximetry sensors will be used (EQUANOX Advanced 9004CB-NA Paediatric/Neonatal). The Paediatric/Neonatal sensors have the advantage of having a completely flat surface to avoid pressure-related injury on fragile skin of infants. They will be attached to infants using soft elastic bandages or a Tegaderm, which are routinely used in clinical practice. The sensors will be positioned using a standard template to minimise inter-observer variability in sensor placement. The following organ systems will be studied: Brain: Left fronto-parietal area of infant’s head. Two lateral LED emitters should avoid the midline (to avoid interference by the sagittal sinus) and hair. Somatic (splanchnic bed): Anterior abdominal wall in the midline 2cm below the umbilicus Cardiorespiratory stability 1. Heart rate and peripheral arterial saturation will be recorded using a pulse oximeter for 1 hour prior to retinopathy screening, during instillation if eye drops, during ophthalmic examination and for 3 hours post examination. 2. Non-invasive, intermittent blood pressure monitoring will be performed using a neonatal blood pressure cuffs for prior to retinopathy screening, after instillation of eye drops, and after eye examination. 3. Ultrasound doppler will be used to measure abdominal blood flow velocities in the coeliac trunk. Position of infants Infants will be placed supine during data collection unless medically indicated for them to lie in other positions (sleep position of infants will be recorded as part of study). This is because sleep position is known to affect parameters of cardiorespiratory stability.
Sponsors
University of Otago
Eligibility
Sex/Gender
All
Age
No minimum to 2 Months
Healthy volunteers
No
Inclusion criteria
Infants will be considered for recruitment into the study if they meet the criteria for screening for ROP Eye checks are performed on • All infants <1301 grams birth weight and all infants <31 weeks gestation at birth. [one criteria only needs to be met] • Infants >1300 grams and >31 weeks will be referred for ROP screening only if the clinical course has been unstable and the infant is felt to be at high risk for ROP e.g. an infant who has required high Heart Rate and concentrations of oxygen Timing of the first examination • Infants, 27 weeks at birth [i.e. up to 26+6] : first exam at 30-31 weeks post menstrual age • Infants 27 weeks or beyond: first exam at 4-5 weeks [29-35 days ] post natal age
Exclusion criteria
If the clinicians caring for the baby consider that participation in the trial would be detrimental to the neonate or compromise the care being provided to the neonate then the patient would not be considered eligible.
Outcome results
None listed