A Qualitative Study of the Experiences of Norwegian Parents of Very Low Birthweight Infants Enrolled in a Randomized Nutritional Trial.

PURPOSE: The aim of this study was to examine how parents of very low birth weight (VLBW) infants experienced having their newborn infant enrolled in a randomized controlled intervention trial (RCT).

DESIGN AND METHODS: A qualitative descriptive design was used. Data were collected through individual semi-structured interviews with 15 parents of 9 participating VLBW infants. The data were then made the object of an inductive qualitative content analysis.

RESULTS: The parents expressed trust in the competence and motivation of the researchers and were confident that participating in the project would do no harm, but instead would potentially benefit their infant. The parents felt privileged for being given the chance to participate, to commit to the project; they were willing to invest their time and effort in the project. Participation could be stressful for the parents, ranging from minor irritation to situations in which they felt overwhelmed and not entirely in control. Many families lived stressful lives, and participation, particularly the follow-up after being discharged, may have added to this.

CONCLUSIONS: Infant participation in an RCT can be a positive experience, making the parents feel that they are given a chance to both contribute and receive something special. Participation can also be stressful because of conditions both related and unrelated to the RCT.

PRACTICE IMPLICATIONS: We identified several issues that researchers in future trials with VLBW infants need to address to minimize parental stress. Recruitment to intervention studies within the immediate period around birth should be avoided, if possible.