Consensus Based Definition of Growth Restriction in the Newborn

Beune, Irene; Bloomfield, Frank H.; Ganzevoort, Wessel; Embleton, Nicholas D.; Rozance, Paul J.; Wassenaer-Leemhuis, Aleid G. van; Wynia, Klaske; Gordijn, Sanne J.

doi:10.1016/j.jpeds.2017.12.059

Cited by 134 publications

(165 citation statements)

References 20 publications

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“…These challenges could be mitigated if it were possible to agree, in advance, about which study data should be collected. We previously have reported on a consensus procedure for the antenatal diagnosis of FGR, 6 the diagnosis of FGR in the newborn period, 7 and a minimum reporting set of study variables for FGR research studies. 8 In this study, we aimed to develop consensus among international stakeholders on a set of core outcomes that should be used in trials that evaluate (1) preventative or (2) therapeutic interventions for FGR.…”

mentioning

confidence: 99%

A Core Outcome Set for the prevention and treatment of fetal GROwth restriction: deVeloping Endpoints: the COSGROVE study

Healy

Gordijn

Ganzevoort

et al. 2019

American Journal of Obstetrics and Gynecology

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BACKGROUND: Fetal growth restriction refers to a fetus that does not reach its genetically predetermined growth potential. It is well-recognized that growth-restricted fetuses are at increased risk of both short-and longterm adverse outcomes. Systematic evaluation of the evidence from clinical trials of fetal growth restriction is often difficult because of variation in the outcomes that are measured and reported. The development of core outcome sets for fetal growth restriction studies would enable future trials to measure similar meaningful outcomes. OBJECTIVE: The purpose of this study was to develop core outcome sets for trials of prevention or treatment of fetal growth restriction. STUDY DESIGN: This was a Delphi consensus study. A comprehensive literature review was conducted to identify outcomes that were reported in studies of prevention or treatment of fetal growth restriction. All outcomes were presented for prioritization to key stakeholders (135 healthcare providers, 68 researchers/academics, and 35 members of the public) in 3 rounds of online Delphi surveys. A priori consensus criteria were used to reach agreement on the final outcomes for inclusion in the core outcome set at a face-to-face meeting with 5 healthcare providers, 5 researchers/academics, and 6 maternity service users. RESULTS: In total, 22 outcomes were included in the final core outcome set. These outcomes were grouped under 4 domains: maternal (n¼4), fetal (n¼1), neonatal (n¼12), and childhood (n¼5). CONCLUSION: The Core Outcome Set for the prevention and treatment of fetal GROwth restriction: deVeloping Endpoints study identified a large number of potentially relevant outcomes and then reached consensus on those factors that, as a minimum, should be measured and reported in all future trials of prevention or treatment of fetal growth restriction. This will enable future trials to measure similar meaningful outcomes and to ensure that findings from different studies can be compared and combined.

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mentioning

confidence: 99%

A Core Outcome Set for the prevention and treatment of fetal GROwth restriction: deVeloping Endpoints: the COSGROVE study

Healy

Gordijn

Ganzevoort

et al. 2019

American Journal of Obstetrics and Gynecology

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“…In the present study, we also use maternal pregnancy information, doppler and biometrics measurements of fetal ultrasound, in addition to other neonatal measures such as head circumference or body length. According to a recent consensus, 22 where these measures were considered, all our term infants SGA meet the criteria for IUGR definition. This consensus concluded that this definition (three of the following: birthweight <10th percentile; head circumference <10th percentile; length <10th percentile; prenatal diagnosis of IUGR; and maternal pregnancy information) "could be adopted in clinical practice and in clinical trials to better focus on newborns at risk".…”

Section: Discussion/conclusion Perinatal Datamentioning

confidence: 99%

Assessment of neonatal EEG background and neurodevelopment in full-term small for their gestational age infants

et al. 2019

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BACKGROUND: Delayed brain function development in small-gestational-age (SGA) infants has been reported. We aimed to quantify rates of immature neonatal EEG patterns and their association with neurodevelopment in SGA full-term neonates. METHODS: Using a cohort design, 50 SGA (birthweight <10th percentile) and 44 appropriate-gestational-age (AGA) term neonates underwent continuous video-EEG recordings lasting >3 h. Seventy-three of them were assessed at 2-years-old using Bayley-III-Scales. For EEG analysis, several segments of discontinuous/alternating EEG tracings were selected. Main outcomes measured: (1) Visual analysis (patterns of EEG maturity); (2) Power spectrum in δ, θ, α and β frequency bands; and (3) scores in motor, cognitive and language development. RESULTS: (1) SGA infants, compared to AGA, showed: (a) higher percentages of discontinuous EEG, both asynchrony and interhemispheric asymmetry, and bursts with delta-brushes, longer interburst-interval duration and more transients/hour; (b) lower relative power spectrum in δ and higher in α; and (c) lower scores on motor, language and cognitive neurodevelopment. (2) Asymmetry >5%, interburst-interval >5 s, discontinuity >11%, and bursts with delta-brushes >11% were associated with lower scores on Bayley-III. CONCLUSIONS: In this prospective study, SGA full-term neonates showed high rates of immature EEG patterns. Low-birthweight and immaturity EEG were both correlated with low development scores.

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“…Based on previous studies, the authors of this study defined consensus as 4 using a 5-point Likert scale. 20,21 The authors of this study choose to define consensus as 85% agreement to be conservative given that previous studies have demonstrated that the median threshold to define consensus is 75% agreement. 22 Statistical analysis was performed using descriptive statistics to calculate percentages for each level of agreement for each scenario and mean and standard deviation of associated group rankings using importance ratings.…”

Section: Delphi Methodsmentioning

confidence: 99%

The utility of the delphi method in defining anastomotic leak following colorectal surgery

Daniel

Alavi

Davids

et al. 2020

The American Journal of Surgery

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Consensus Based Definition of Growth Restriction in the Newborn

Cited by 134 publications

References 20 publications

A Core Outcome Set for the prevention and treatment of fetal GROwth restriction: deVeloping Endpoints: the COSGROVE study

A Core Outcome Set for the prevention and treatment of fetal GROwth restriction: deVeloping Endpoints: the COSGROVE study

Assessment of neonatal EEG background and neurodevelopment in full-term small for their gestational age infants

The utility of the delphi method in defining anastomotic leak following colorectal surgery

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