Traditionally, surgical intervention has been the standard treatment for children with metopic synostosis, assuming that it reduces the risk of raised intracranial pressure, thereby preventing vision and cognitive impairment, and also restores the abnormal head shape. However, recent research suggests a sporadic occurrence of raised intracranial pressure in patients with metopic synostosis. In addition, following surgery, an overall tendency to have worse cognitive and behavioral outcomes and more refractive errors compared to healthy peers is observed. Research on conservative (non-surgical) treatment in metopic synostosis is limited and lacks a comparative design. The purpose of this study is to compare the (cost-)effectiveness of conservative and surgical treatment in patients with metopic synostosis.

This is the protocol for an observational cohort study with a duration of 8 years. A total of 450 patients with metopic synostosis will be included. The primary outcome is head growth as a predictor for increased intracranial pressure. Non-inferiority with regard to head growth from 0 to 8 years (yearly difference in SD) is determined using a linear mixed model adjusted for potential confounders. Secondary outcomes include papilledema, orthoptic outcomes; forehead shape; cognitive, behavioural and psychological outcomes; and societal costs. A cost-effectiveness analysis will be performed.

The study has been reviewed and approved by the Medical Research Ethics Committee of the Erasmus MC, University Medical Center Rotterdam (MEC-2022-0142). Written informed consent will be obtained from both parents of each participant. The results will be disseminated by publication in international peer-reviewed journals.

ClinicalTrials.gov NCT06069479.

Children with Medical Complexities (CMC) often require 24/7 expert care, which frequently necessitates prolonged (re)admissions to a university medical centre (UMC), thereby impeding discharge to home. The transition from hospital to home for CMC is a multifaceted process with numerous challenges and obstacles. This protocol describes the evaluation of an innovative transitional care unit (TCU), where families can stay together in a home-like environment between hospital and home. Under the supervision of healthcare professionals, parents are supported in preparing for a sustainable home situation. We hypothesise that an intermediate stay at the Jeroen Pit Huis (JPH) will have a favourable effect on healthcare consumption, patient, parent and family-relevant outcomes in comparison to discharge directly from a hospital ward to home. Therefore, the purpose of this study is to compare the transition via the TCU JPH versus transition from hospital ward to home as provided elsewhere for CMC patients in the Netherlands.

This observational prospective cohort study compares patients who transition directly from hospital to home with those who transition via the TCU. The control group comprises five UMCs in the Netherlands. Data will be collected by extracting information from electronic health records and through online questionnaires. Parents complete questionnaires at three time points: on discharge home, 3 months and 12 months postdischarge. Bayesian inverse probability weighting will be used to control for confounding effects and analyse the results.

Ethical approval was granted by the Amsterdam UMC Medical Ethics Committee (W20_220#20.007). The need for ethical approval was waived by all other participating UMCs. Results will be disseminated through peer-reviewed scientific journals and conference presentations. The insights gained from this study will contribute to the development of a national care pathway to enhance transitional care for CMC and their families in the future.

NCT06599398 (ClinicalTrials.gov) - Bridging Hospital to Home for CMC and Their Families.