TY - JOUR
T1 - Cerebral oximetry monitoring versus usual care for extremely preterm infants
T2 - a study protocol for the 2-year follow-up of the SafeBoosC-III randomised clinical trial
AU - Rasmussen, Marie Isabel
AU - Hansen, Mathias Lühr
AU - Pellicer, Adelina
AU - Gluud, Christian
AU - Dempsey, Eugene
AU - Mintzer, Jonathan
AU - Hyttel-Sørensen, Simon
AU - Heuchan, Anne Marie
AU - Hagmann, Cornelia
AU - Ergenekon, Ebru
AU - Dimitriou, Gabriel
AU - Pichler, Gerhard
AU - Naulaers, Gunnar
AU - Cheng, Guoqiang
AU - Tkaczyk, Jakub
AU - Fuchs, Hans
AU - Fumagalli, Monica
AU - Nesargi, Saudamini
AU - Fredly, Siv
AU - Szczapa, Tomasz
AU - Plomgaard, Anne Mette
AU - Hansen, Bo Mølholm
AU - Jakobsen, Janus Christian
AU - Greisen, Gorm
N1 - © 2023. BioMed Central Ltd., part of Springer Nature.
PY - 2023/10/7
Y1 - 2023/10/7
N2 - BACKGROUND: In the SafeBoosC-III trial, treatment guided by cerebral oximetry monitoring for the first 72 hours after birth did not reduce the incidence of death or severe brain injury in extremely preterm infants at 36 weeks' postmenstrual age, as compared with usual care. Despite an association between severe brain injury diagnosed in the neonatal period and later neurodevelopmental disability, this relationship is not always strong. The objective of the SafeBoosC-III follow-up study is to assess mortality, neurodevelopmental disability, or any harm in trial participants at 2 years of corrected age. One important challenge is the lack of funding for local costs for a trial-specific assessment.METHODS: Of the 1601 infants randomised in the SafeBoosC-III trial, 1276 infants were alive at 36 weeks' postmenstrual age and will potentially be available for the 2-year follow-up. Inclusion criteria will be enrollment in a neonatal intensive care unit taking part in the follow-up study and parental consent if required by local regulations. We aim to collect data from routine follow-up programmes between the ages of 18 and 30 months of corrected age. If no routine follow-up has been conducted, we will collect informal assessments from other health care records from the age of at least 12 months. A local co-investigator blinded to group allocation will classify outcomes based on these records. We will supplement this with parental questionnaires including the Parent Report of Children's Abilities-Revised. There will be two co-primary outcomes: the composite of death or moderate or severe neurodevelopmental disability and mean Bayley-III/IV cognitive score. We will use a 3-tier model for prioritisation, based on the quality of data. This approach has been chosen to minimise loss to follow-up assuming that little data is better than no data at all.DISCUSSION: Follow-up at the age of 2 years is important for intervention trials in the newborn period as only time can show real benefits and harms later in childhood. To decrease the risk of generalisation and data-driven biased conclusions, we present a detailed description of the methodology for the SafeBoosC-III follow-up study. As funding is limited, a pragmatic approach is necessary.TRIAL REGISTRATION: ClinicalTrials.gov NCT05134116 . Registered on 24 November 2021.
AB - BACKGROUND: In the SafeBoosC-III trial, treatment guided by cerebral oximetry monitoring for the first 72 hours after birth did not reduce the incidence of death or severe brain injury in extremely preterm infants at 36 weeks' postmenstrual age, as compared with usual care. Despite an association between severe brain injury diagnosed in the neonatal period and later neurodevelopmental disability, this relationship is not always strong. The objective of the SafeBoosC-III follow-up study is to assess mortality, neurodevelopmental disability, or any harm in trial participants at 2 years of corrected age. One important challenge is the lack of funding for local costs for a trial-specific assessment.METHODS: Of the 1601 infants randomised in the SafeBoosC-III trial, 1276 infants were alive at 36 weeks' postmenstrual age and will potentially be available for the 2-year follow-up. Inclusion criteria will be enrollment in a neonatal intensive care unit taking part in the follow-up study and parental consent if required by local regulations. We aim to collect data from routine follow-up programmes between the ages of 18 and 30 months of corrected age. If no routine follow-up has been conducted, we will collect informal assessments from other health care records from the age of at least 12 months. A local co-investigator blinded to group allocation will classify outcomes based on these records. We will supplement this with parental questionnaires including the Parent Report of Children's Abilities-Revised. There will be two co-primary outcomes: the composite of death or moderate or severe neurodevelopmental disability and mean Bayley-III/IV cognitive score. We will use a 3-tier model for prioritisation, based on the quality of data. This approach has been chosen to minimise loss to follow-up assuming that little data is better than no data at all.DISCUSSION: Follow-up at the age of 2 years is important for intervention trials in the newborn period as only time can show real benefits and harms later in childhood. To decrease the risk of generalisation and data-driven biased conclusions, we present a detailed description of the methodology for the SafeBoosC-III follow-up study. As funding is limited, a pragmatic approach is necessary.TRIAL REGISTRATION: ClinicalTrials.gov NCT05134116 . Registered on 24 November 2021.
KW - Brain injury
KW - Follow-up
KW - Near-infrared spectroscopy
KW - Neurodevelopment
KW - Preterm
KW - Protocol
KW - Randomised clinical trial
UR - http://www.scopus.com/inward/record.url?scp=85173673717&partnerID=8YFLogxK
U2 - 10.1186/s13063-023-07653-x
DO - 10.1186/s13063-023-07653-x
M3 - Journal article
C2 - 37805539
SN - 1745-6215
VL - 24
JO - Trials
JF - Trials
IS - 1
M1 - 653
ER -