Core Outcome Set for Necrotizing Enterocolitis Treatment Trials.

BACKGROUND AND OBJECTIVES: Variability in outcome reporting in necrotizing enterocolitis (NEC) treatment trials hinders conducting meta-analyses and implementing novel treatments. We aimed to develop a core outcome set (COS) for NEC treatment trials including outcome measures most relevant to patients and physicians, from NEC diagnosis to adulthood. METHODS: Clinicians and/or researchers from low-middle- and high-income countries were approached based on their scientific contributions to NEC literature, and patients and parents through local organizations. We presented participants with 45 outcomes used in NEC research, identified through a systematic review. To achieve consensus, outcomes were rated on a scale of 1 to 9 in 3 online Delphi rounds, and discussed at a final consensus meeting. RESULTS: Seventy-one participants from 25 countries completed all Delphi rounds, including 15 patients and family representatives. Thirteen outcomes reached consensus in one of the stakeholder groups and were included in the consensus meeting, 6 outcomes reached consensus in both groups. Twenty-seven participants from both high- and low-middle-income countries attended the online consensus meeting, including family representatives and NEC patients. After discussion and a final vote, 5 outcomes reached consensus to be included: mortality, NEC-related mortality, short bowel syndrome, quality of life, and neurodevelopmental impairment. CONCLUSIONS: This NEC COS includes 5 predominantly long-term outcomes agreed upon by clinicians, patients, and family representatives. Use of this international COS will help standardize outcome selection in clinical trials, ensure these are relevant to those most affected by NEC care, and, ultimately, improve the care of infants with NEC.

European Association of Perinatal Medicine (EAPM), European Board and College of Obstetricians and Gynaecologists (EBCOG), European Midwives Association (EMA). Joint position statement: Substandard and disrespectful care in labour - because words matter.

Substandard or disrespectful care during labour should be of serious concern for healthcare professionals, as it can affect one of the most important events in a woman's life. Substandard care refers to the use of interventions that are not considered best-practice, to the inadequate execution of interventions, to situations where best-practice interventions are withheld from patients, or there is lack of adequate informed consent. Disrespectful care refers to forms of verbal and non-verbal communication that affect patients' dignity, individuality, privacy, intimacy, or personal beliefs. There are many possible underlying causes for substandard and disrespectful care in labour, including difficulties in modifying behaviours, judgmental or paternalistic attitudes, personal interests and individualism, and a human tendency to make less arduous, less difficult, or less stressful clinical decisions. The term "obstetric violence" is used in some parts of the world to describe various forms of substandard and disrespectful care in labour, but suggests that it is mainly carried out by obstetricians and is a serious form of aggression, carried out with the intent to cause harm. We believe that this term should not be used, as it does not help to identify the underlying problem, its causes, or its correction. In addition, it is generally seen by obstetricians and other healthcare professionals as an unjust and offensive term, generating a defensive and less collaborative mindset. We reach out to all individuals and institutions sharing the common goal of improving women's experience during labour, to work together to address the underlying causes of substandard and disrespectful care, and to develop common strategies to deal with this problem, based on mutual comprehension, trust and respect.

Outcomes following the adoption of standard parenteral nutrition in preterm infants: a whole-population non-concurrent control study.

OBJECTIVE: To evaluate the impact of a quality improvement project of the adoption of standard parenteral nutrition (SPN) in preterm infants. DESIGN: Retrospective, multicentre, whole-population, non-concurrent control study using data from the UK National Neonatal Research Database between 1 January 2014 and 31 December 2020. SETTING: Neonatal units in London UK organised by geographical network. PATIENTS: Preterm infants <31 weeks' gestation. INTERVENTIONS: Introduction of two SPN formulations previously tested in randomised controlled trials (NEON and SCAMP). SCAMP delivers a higher target macronutrient intake. MAIN OUTCOME MEASURES: The primary outcome was survival to discharge from neonatal care without major morbidities. Secondary outcomes included the individual components of the primary outcome and a comparison of outcomes between the NEON and the SCAMP formulations. RESULTS: Of 6538 eligible infants, 4693 were admitted to neonatal care before and 1845 after the adoption of SPN. Morbidity-free survival decreased by an average of 8.6% (95% CI 5.8% to 11.4%, p<0.0001) following adoption. The effect varied by type of formulation; the cohort that adopted NEON showed no difference in morbidity-free survival, whereas the cohort that adopted SCAMP showed a statistically significant decrease in morbidity-free survival. Overall survival decreased by an average of 2.0% (95% CI 0.01% to 4.0%, p=0.048). CONCLUSIONS: Research is urgently needed to identify the optimal composition of parenteral nutrition for preterm babies. This study also adds to the growing body of evidence that suggests that early and high intakes of macronutrients in preterm babies may be harmful.

Projected health and economic effects of the increase in childhood obesity during the COVID-19 pandemic in England: The potential cost of inaction.

BACKGROUND: The prevalence of overweight and obesity in young children rose sharply during the COVID-19 pandemic. Here we estimate the potential future health and economic effects of these trends in England. METHODS: Using publicly available annual Body Mass Index (BMI) data from 2006-2022, we calculated the increase in overweight/obesity prevalence (BMI ≥85th reference percentile) during the COVID-19 pandemic among children aged 4-5 and 10-11, and variation by deprivation and ethnicity. We projected the impact of child BMI trends on adult health measures to estimate added lifelong medical and social costs. RESULTS: During 2020-2021 there were steep increases in overweight and obesity prevalence in children. By 2022, overweight and obesity prevalence in children aged 4-5 returned to expected levels based on pre-pandemic trends. However, overweight and obesity prevalence in children aged 10-11 persisted and was 4 percentage points (p<0.001) higher than expected, representing almost 56,000 additional children. The increase was twice as high in the most compared with the least deprived areas. The additional lifelong healthcare cost in this cohort will amount to £800 million with a cost to society of £8.7 billion. We did not find an increase in maternal obesity associated with the COVID-19 pandemic, however, prevalence grew faster in the post pandemic period. DISCUSSION: The return of overweight and obesity prevalence to pre-pandemic trends in children aged 4-5 provides a clear policy target for effective intervention to tackle this growing and serious population health concern.

EUROPEAN ASSOCIATION OF PERINATAL MEDICINE (EAPM) EUROPEAN MIDWIVES ASSOCIATION (EMA) Joint position statement: Caesarean delivery rates at a country level should be in the 15-20 % range.

While cesarean deliveries performed for health indications can save lives, unnecessary cesareans cause unjustifiable health risks for the mother, newborn, and for future pregnancies. Previous recommendations for cesarean delivery rates at a country level in the 10-15% range are currently unrealistic, and the proposed concept that striving to achieve specific rates is not important has resulted in a confusing message reaching healthcare professionals and the public. It is important to have a clear understanding of when cesarean delivery rates are deviating from internationally acceptable ranges, to trigger the implementation of healthcare policies needed to correct this problem. Based on currently existing scientific evidence, we recommend that cesarean delivery rates at a country level should be in the 15-20% range. This advice is based on the demonstration of decreased maternal and neonatal mortalities when national cesarean delivery rates rise to circa 15%, but values exceeding 20% are not associated with further benefits. It is also based on real-world experiences from northern European countries, where cesarean delivery rates in the 15-20% range are associated with some of the best maternal and perinatal quality indicators in the world. With the increase in cesarean delivery rates projected for the coming years, experience in provision of intrapartum care may come under threat in many hospitals, and recovering from this situation is likely to be a major challenge. Professional and scientific societies, together with healthcare authorities and governments need to prioritize actions to reverse the upward trend in cesarean delivery rates observed in many countries, and to strive to achieve values as close as possible to the recommended range.

Preterm Formula, Fortified or Unfortified Human Milk for Very Preterm Infants, the PREMFOOD Study: A Parallel Randomised Feasibility Trial.

OBJECTIVE: Uncertainty exists regarding optimal supplemental diet for very preterm infants if the mother's own milk (MM) is insufficient. We evaluated feasibility for a randomised controlled trial (RCT) powered to detect important differences in health outcomes. METHODS: In this open, parallel, feasibility trial, we randomised infants 25+0-31+6 weeks of gestation by opt-out consent to one of three diets: unfortified human milk (UHM) (unfortified MM and/or unfortified pasteurised human donor milk (DM) supplement), fortified human milk (FHM) (fortified MM and/or fortified DM supplement), and unfortified MM and/or preterm formula (PTF) supplement from birth to 35+0 weeks post menstrual age. Feasibility outcomes included opt-outs, adherence rates, and slow growth safety criteria. We also obtained anthropometry, and magnetic resonance imaging body composition data at term and term plus 6 weeks (opt-in consent). RESULTS: Of 35 infants randomised to UHM, 34 to FHM, and 34 to PTF groups, 21, 19, and 24 infants completed imaging at term, respectively. Study entry opt-out rate was 38%; 6% of parents subsequently withdrew from feeding intervention. Two infants met predefined slow weight gain thresholds. There were no significant between-group differences in term total adipose tissue volume (mean [SD]: UHM: 0.870 L [0.35 L]; FHM: 0.889 L [0.31 L]; PTF: 0.809 L [0.25 L], p = 0.66), nor in any other body composition measure or anthropometry at either timepoint. CONCLUSIONS: Randomisation to UHM, FHM, and PTF diets by opt-out consent was acceptable to parents and clinical teams, associated with safe growth profiles and no significant differences in body composition. Our data provide justification to proceed to a larger RCT.

Infant fat mass and later child and adolescent health outcomes: a systematic review.

OBJECTIVE: Obesity and excess adiposity are leading causes of metabolic and cardiovascular morbidity and mortality. Early identification of individuals at risk is key for preventive strategies. We examined the relationship between infant body composition (0-2 years of age) and later (>2 years) health outcomes using a systematic review. DESIGN: We preregistered the study on PROSPERO (ID 288013) and searched Embase, PubMed and Cochrane databases for English language publications using the Medical Subject Headings (MeSH) terms 'infant' and 'body composition' and 'risk' between January 1946 and February 2022. We included studies which assessed infant body composition using predetermined in vivo methods other than body mass index (BMI). RESULTS: We identified 6015 articles. After abstract screening to assess eligibility, we reviewed 130 full text publications. 30 were included in the final assessment and narrative synthesis. Meta-analysis was not possible due to heterogeneity of results. All 30 studies were of high quality and reported associations between infant body composition and 19 different health outcomes after 2 years of age. Outcome measurements ranged from 2 years to 16 years. The strongest associations were found between infant fat mass and later fat mass (7 studies), and later BMI (5 studies). For 11 of the outcomes assessed, there was no relationship to infant adiposity detected. CONCLUSIONS: Current evidence, from a small number of studies, suggests a positive association between infant adiposity and future adiposity or BMI, but the validity of infant body composition as a biomarker of future health remains inconclusive. Carefully designed, standardised studies are required to identify the value of infant body composition for predicting later health. TRIAL REGISTRATION: PROSPERO: 288013.

Two-year neurodevelopmental data for preterm infants born over an 11-year period in England and Wales, 2008-2018: a retrospective study using the National Neonatal Research Database.

OBJECTIVE: United Kingdom guidelines recommend all infants born <30 weeks' gestation receive neurodevelopmental follow-up at 2 years corrected age. In this study, we describe completeness and results of 2-year neurodevelopmental records in the National Neonatal Research Database (NNRD). DESIGN: This retrospective cohort study uses data from the NNRD, which holds data on all neonatal admissions in England and Wales, including 2year follow-up status. PATIENTS: We included all preterm infants born <30 weeks' gestation between 1 January 2008 and 31 December 2018 in England and Wales, who survived to discharge from neonatal care. MAIN OUTCOME MEASURES: Presence of a 2-year neurodevelopmental assessment record in the NNRD, use of standardised assessment tools, results of functional 2-year neurodevelopmental assessments (visual, auditory, neuromotor, communication, overall development). RESULTS: Of the 41 505 infants included, 24 125 (58%) had a 2-year neurodevelopmental assessment recorded. This improved over time, from 32% to 71% for births in 2008 and 2018, respectively.Of those with available data: 0.4% were blind; 1% had a hearing impairment not correctable with aids; 13% had <5 meaningful words, vocalisations or signs; 8% could not walk without assistance and 9% had severe (≥12 months) developmental delay. CONCLUSIONS: The proportion of infants admitted to neonatal units in England and Wales with a 2-year neurodevelopmental record has improved over time. Rates of follow-up data from recent years are comparable to those of bespoke observational studies. With continual improvement in data completeness, the potential for use of NNRD as a source of longer-term outcome data can be realised.

Clinical outcomes of Staphylococcus capitis isolation from neonates, England, 2015-2021: a retrospective case-control study.

OBJECTIVE: Staphylococcus capitis, a coagulase-negative staphylococci (CoNS) species, has been increasingly detected from UK sterile site samples and has caused neonatal unit outbreaks worldwide. We compared survival to discharge and 30-day mortality for the detection of S. capitis versus other CoNS species. METHODS: In this retrospective case-control study, we included hospitalised infants with any CoNS species detected from a normally sterile body site up to 90 days of age. We linked English laboratory reports from the Second Generation Surveillance System database, mortality data from the Personal Demographics Service, and neonatal unit admissions from the National Neonatal Research Database. In primary analysis, multivariable logistic regression was used, with two co-primary outcomes: survival to discharge and death within 30 days of positive specimen date. Sensitivity analyses using multiply imputed datasets followed. RESULTS: We identified 16 636 CoNS episodes relating to 13 745 infants. CoNS episodes were highest among infants born extremely preterm (22-27 weeks) and with extremely low birth weight (400-999 g). In primary analysis, there were no differences in survival to discharge (p=0.71) or 30-day mortality (p=0.77) between CoNS species. In sensitivity analyses, there were no differences in outcomes between infection with four of the most common CoNS species (Staphylococcus epidermidis, S. capitis, Staphylococcus haemolyticus and Staphylococcus warneri) but the remaining CoNS species were at higher risk of adverse outcomes when treated in aggregate. CONCLUSION: Infants with S. capitis detected from sterile site samples did not experience significant differences in either survival to discharge or 30-day mortality compared with infants with detection of other common CoNS species.

Paid leave to support parenting-A neglected tool to improve societal well-being and prosperity.

Cohesive families and stimulating and caring environments promoting attachment to caregivers is fundamental for a child's physical and psychosocial growth and development. Parental care, supporting early years development, presupposes the presence and involvement of parents in children's daily life with activities that include breastfeeding, playing, reading and storytelling. However, parents have to balance their child's well-being against employment, career progression and gender equality. Universally accessible and equitably available parental leave addresses this challenge. CONCLUSION: Distinct from compulsory maternity leave, leave at full or nearly full pay for both parents benefits not only families but also societal well-being and prosperity.

Global Association of the COVID-19 Pandemic With Pediatric Clinical Trial Publication.

This cross-sectional study investigates the association of the COVID-19 pandemic with rates of pediatric clinical trial publication.