Research involving young infants is essential to derive investigational and therapeutic innovations to benefit this group. However, there is often a reluctance on the part of health professionals to enrol neonates in research studies that involve interventions such as blood sampling due to a perceived maternal reluctance to participate (Mason et al, 2000). Parents have the right to participate in research, but they must have detailed information about the research study in order to exercise this right. Woolfall et al (2013) observed that the main factors that contributed to a decision about research participation included the clinical benefit that the child might derive balanced against the practicalities of participation and potential for harm. As well as considering the implications for their child, altruism and desire for the collective good are also motivating factors for parents, as long as the hypothetical risk to their own child is small (Hoehn et al, 2005; Sammons et al, 2007; Wendler and Jenkins, 2008; Woolfall, 2013). However, there is a paucity of literature on parental reactions towards research involving healthy newborn infants. In order to understand the acceptability of our research to participants and ensure patient and public involvement in the study (PPI), a questionnaire was administered at the end of participation in the research project. The study aimed to investigate the motivating factors that influenced participation in a mother-infant study and how women felt about blood being collected from themselves and their infants.
Methods
Between March 2011 and January 2012, a cohort study was conducted to investigate the concentration of maternal- and infant-specific antibodies to vaccines against preventable infections (Jones et al, 2013; Jones et al, 2014). As part of this study, maternal attitudes towards participation in research were assessed, using a self-administered questionnaire at study exit. The study was approved by the National Research Ethics Service and funded by the National Institute for Health Research (NIHR) Biomedical Research Centre based at the Imperial College Healthcare NHS Trust and Imperial College.
Participant recruitment
Study-specific information was available to women in an antenatal clinic at Imperial College Healthcare NHS Trust. A research midwife subsequently approached postpartum mothers on the postnatal wards within 3 days of birth to invite them to participate in the study. Women were approached at a convenient time to avoid interrupting feeding, sleeping or clinical care. The aims of the research were presented and the parent information leaflet was left with women to read in their own time. The researcher then returned later in the day to discuss the study further with interested families.
Eligible women who agreed to participate gave written informed consent for themselves and their infants. Mother–baby pairs were eligible for the study if the mother had given birth to a live baby in the previous 72 hours. Mother–baby pairs were excluded if the mother was less than 18 years of age, unwell or intending to leave the study area within the next 5 months. Babies were excluded if they were born at less than 36 weeks gestation, weighed less than 2500 g or were unwell. Blood borne viruses, including HIV, were not an exclusion criteria. Consecutive eligible women were enrolled in the study, irrespective of HIV infection status.
Study measures
Demographic, pregnancy and birth details were recorded for each mother–baby pair. Up to 5 ml of venous blood was collected from participating mothers and up to 1 ml of capillary blood was collected by heel prick from the baby. Email, text or postal contact was made, according to maternal preference, to remind participating mothers to attend their general practice for routine infant vaccinations, which were administered according to the UK immunisation schedule. Mothers and babies were asked to return to the paediatric research unit 1 month after completion of the primary vaccinations—at around 5 months of age—for a further venous blood sample from the mother and infant. A paediatrician examined all babies at this visit.
Following these study procedures, mothers were asked to complete a questionnaire relating to their experiences in the study and assessing their reasons for participation. Mothers completed the questionnaire independently; assistance was only given for clarification of terminology. The questionnaire consisted of 13 questions (see Figure 1 for six of the questions asked; the other seven questions related to decision-making about vaccination). Women spent on average less than 10 minutes completing the questionnaire.
Data management
Data from the questionnaire was entered into a study-specific database that contained no patient-identifiable information. Microsoft Excel was used to analyse responses.
Results
Of the 485 women screened for eligibility, 387 were asked to participate and 115 mother–baby pairs were recruited to the study. Of this cohort, 67 pairs returned for follow-up and completed the exit questionnaire (58%). Table 1 shows the demographic characteristics of the study cohort.
| Maternal characteristics | n (%) |
|---|---|
| Ethnicity | |
| Asian or Asian British | 8 (7%) |
| Black or Black British | 34 (30%) |
| White British | 20 (18%) |
| Other White background | 26 (23%) |
| Mixed or other ethnic background | 24 (22%) |
| Maternal age, median (IQR) | 31.84 (27.22–35.66) |
| Maternal HIV infection | 12 (11%) |
| Infant characteristics | |
| Gestation, median (IQR) in weeks | 40 (39–41) |
| Female | 55 (49%) |
| Delivered by caesarean section | 44 (40%) |
| Birth weight, median (IQR) in kg | 3.29 (2.99–3.60) |
| Exclusive breastfeeding at birth | 70 (63%) |
Participating women reported a number of reasons for choosing to participate in the study. The most common reason given was that women wanted to help scientific research (n=29; 44%), other women participated because they were asked (n=24; 37%) or because they thought the study would be of direct benefit to their baby (n=11; 17%); however, a minority of women were unsure why they participated (n=3; 2%).
It was found that collection of blood samples from mothers and babies at birth and again at 5 months of age was largely acceptable to the women that took part in the study (Figure 2). Most mothers reported that they did not mind having the blood test done either at birth or at 5 months post-birth, and only a small number found the procedure upsetting. Those mothers who found the blood test at birth very upsetting returned for follow-up for a second blood test. In contrast, around one third of women found the blood test from their baby a little upsetting at birth and at 5 months of age. However, the majority said they did not mind.
Women were asked whether the study had been useful to help remind them to attend their GP practice for vaccinations. Most women found the reminders useful (n=46; 69%), 9 women (14%) reported it was somewhat useful, 8 women (12%) did not find it useful and 4 (5%) did not know.
Discussion
This study has demonstrated that new mothers are willing to participate in a research study involving blood sampling from their newborn and to return for a follow-up blood sample, even when there is little benefit for themselves or their baby. In line with other studies, participating mothers demonstrated altruism and a willingness to advance research (van Stuijvenberg et al, 1998).
It was found that approaching new mothers was largely acceptable. Women were generally more positive about taking part in a research than had been expected. Shilling (2011) also observed that parents are more positive about being approached to enter their child into a clinical trial than practitioners anticipated.
A full explanation, time spent with parents and availability to answer questions were integral in gaining trust and consent. It was advantageous to have a research midwife discussing the study with families as the needs of a postnatal mother could be appreciated. Furthermore, integration and communication with the clinical midwives and minimal disruption of the working patterns of the ward could be more easily achieved. Providing initial information to women and then returning to speak to them again later in the day or the following day was helpful. It gave women time to consider the study and also to talk to family members about participation in the study. De Mauro et al (2014) found that the ability of the researcher to connect and form a relationship with the participant is an important factor in the decision to take part in a study. It was emphasised that the manner in which information is given is as important as the information itself.
A large number of women eligible to take part in the study did not agree to participate. It would have been interesting to understand the reasons why women declined in more detail; however, informal observation found that women declined for a number of reasons. First, some women were too tired or overwhelmed or sleeping to consider research participation. Only a small number of women expressed that they did not want to participate due to the requirement of the blood sample from their baby and a small number of women refused because they had no intention of having their child vaccinated. Other women declined to participate having already committed to other research projects, although other sources report this is not necessarily an excluding factor as some parents are willing to participate in more than one trial (Morley et al 2005; McKechnie and Gill 2006). It has been suggested as good practice that if parents are approached to consent for more than one study, requests should be made 48 hours apart (Golec et al, 2004).
There was no financial incentive to participate or return for follow-up. Mothers were reimbursed travel expenses only; however, the advantage of having their baby checked by a paediatrician may have been an attraction. McKechnie and Gill (2006) showed that the possibility of receiving the most advanced treatments and the confidence placed in the medical team were highest motivating factors for participation in research.
It was found that maternal blood sampling was largely acceptable to mothers; few women experienced any distress around blood sampling after birth or at 5 months. Although mothers' anxiety around blood sampling of their babies was higher, testing was still acceptable to the majority of mothers at birth and at 5 months.
As a benefit of participation in the study, the majority of women found the vaccination reminders useful in reminding them to attend for their baby's vaccinations.
In line with this study, Cartwright et al (2011) found that parents mostly report positive experiences of research involvement; this should be an encouragement to clinicians to offer the option of enrolment in clinical research.
Limitations
The proportion of women returning for follow-up was only 58%. Securing the follow-up of the mothers and babies at 5 months after the vaccinations had been received was challenging. Successive letters, phone calls and e-mails were sent encouraging attendance. The main reasons that women gave for not attending the follow-up appointment were time or work commitments, childcare issues and distance of travel. Offering home visits rather than requiring participants to come to a dedicated research clinic at the hospital might have improved the cohort retention rate. It is possible that those women who did not return for follow-up were those that found the blood sampling most distressing at birth; however, this was not reflected by the informal feedback that were collected from women.
Conclusion
This study demonstrates that new mothers are willing to participate in a research study involving blood sampling from their newborn and to return for further blood sampling. This should encourage practitioners to invite women and their infants to take part in research projects. This must be done in a sensitive manner and must not interfere with routine clinical care.