4.3. Strengths and Limitations
weight gain
A randomized controlled trial design is the methodology of choice for studying the effects of an intervention. Moreover, blinding of the parents, NICU staff, and outcome accessors minimized bias related to allocation, intervention, and outcome assessment. Transparency is an additional strength of our study; we registered the study on a public research platform and published the complete protocol in a peer-reviewed journal [Evidence on the effect of TF on outcomes other than weight gain velocity is lacking; thus, we aimed to study whether neurodevelopmental scores will improve in the TF group at 12 and 24 months of corrected age. However, due to the early cessation of the study, we could not show the difference between the groups as calculated during planning.The most important limitation of the current study was that it ceased before recruiting the target number of participants. Another limitation is that we did not measure body composition according to the protocol (funds were not obtained). Consequently, despite the effort and funds invested in designing and commencing the trial, we could not obtain results that would add to the existing evidence in the field.However, it is important to emphasize that we identified several potential obstacles to introducing individualized fortification in clinical practice in the NICU. First, frequent measurements of milk composition (twice per week) significantly increased the workload. The potential solution might be to perform the measurement less often, for example, once a week instead of twice a week. Rochow et al. showed that measurements twice weekly led to a mean macronutrient intake within a range of ±5% of the targeted levels [