RecruitingACTRN12618000773235

Studying the effect of retinopathy of prematurity screening on cerebral and gut regional oxygenation.

Effect of Retinopathy Of Prematurity screening on cerebral and somatic (splanchnic) regional oxygenation and cardiovascular stability in neonates (ROP-Ox)

Sponsor

University of Otago

Enrollment

30 participants

Start Date

Apr 24, 2018

Study Type

Observational

Conditions

Retinopathy of Prematurity Prematurity

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.

Eligibility

Sex: Both males and femalesMax Age: 2 Monthss

Plain Language Summary

Simplified for easier understanding

Premature babies — especially those born before 31 weeks or weighing less than 1,300 grams — are routinely checked for a condition called retinopathy of prematurity (ROP), where the blood vessels in the developing eye grow abnormally and can damage vision. The screening involves an ophthalmologist examining the baby's eyes after administering dilating eye drops. While this screening is essential for protecting vision, there is some evidence that it can temporarily affect babies' blood flow to the gut and cause stress responses. This study is using gentle, non-invasive monitoring devices (including near-infrared spectroscopy — essentially a light sensor placed on the skin — and ultrasound of the abdominal blood vessels) to measure exactly what happens to blood flow and oxygen levels in the brain and gut before, during, and for three hours after the eye screening. The goal is to understand which part of the screening process causes these changes so that the procedure can be made as safe as possible. This study involves premature babies who meet the standard criteria for ROP screening. It is purely observational — no changes are made to the screening itself — and participation is decided by the clinical team caring for the baby. No extra blood draws or invasive procedures are involved.

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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 de

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.