The Infant Cuddler Study: Evaluating the effectiveness of volunteer cuddling in infants with neonatal abstinence syndrome

Abstract

Objectives

St. Michael’s Hospital launched a volunteer cuddling program for all infants admitted into the neonatal intensive care unit in October 2015. The program utilizes trained volunteers to cuddle infants when caregivers are not available. This was a pilot study to assess the impact of a volunteer cuddle program on length of stay (LOS) and feasibility of implementation of the program.

Methods

A mixed methods approach was utilized to measure both quantitative and qualitative impact. A pilot cohort study with a retrospective control group assessed the feasibility of implementing a volunteer cuddling program for infants with neonatal abstinence syndrome (NAS). Length of stay was used as a surrogate marker to measure the impact of cuddling on infants being treated for Neonatal Abstinence Syndrome. Focus groups using semi-structured interviews were conducted with volunteers and nurses at the end of the pilot study.

Results

LOS was reduced by 6.36 days (U=34, P=0.072) for infants with NAS in the volunteer cuddling program. Focus groups with both bedside nurses and program volunteers described a positive impact of cuddling programs on infants, families, staff, and volunteers alike.

Conclusions

The study results suggest that the volunteer cuddling program may reduce LOS in infants with NAS and have potential economic savings on hospital resources. However, larger prospective cohort studies are needed to confirm these results.

Whether prescribed or illicit, opioid exposure during pregnancy can produce neonatal withdrawal, also known as neonatal abstinence syndrome (NAS), the incidence of which has rapidly increased over the last decade. The Canadian Institute for Health Information reported for 2016 to 2017, an estimated 0.51% of all infants born in Canada (approximately 1850/year, Quebec excluded) had NAS (1).

Currently, opioid agonist therapy (OAT) such as methadone or buprenorphine is the standard of care for maternal opioid use disorder in pregnancy (2). OAT during pregnancy has been reported to lessen the use of other opioids and illicit drugs and improve prenatal care, including access to education, counselling, and supportive community services (3,4). Onset of withdrawal symptoms is dependent on the half-life of the opioid and may be potentiated by polydrug exposure as well as benzodiazepines and antidepressants.

NAS is characterized by multisystem drug withdrawal symptoms including respiratory (sneezing, nasal congestion), gastrointestinal (vomiting, diarrhea, poor feeding, poor growth), central nervous system (irritability, high-pitch and excessive crying, tremors, seizures; oral-motor discoordination), and autonomic system (fever, sweating). Estimates show that up to 94% of infants exposed to opiates in utero will display withdrawal symptoms while approximately 50% to 75% of infants born to women on opioids will require treatment for opioid withdrawal (5–7). However, the need for treatment may not be recognized in preterm infants who may not demonstrate classic NAS symptoms due to immature respiratory, central nervous, gastrointestinal, and autonomic systems. Late preterm infants are known to have lower severity of NAS compared to term infants but longer hospital stays (8, 9). Morphine is the most frequently used medication to treat NAS in Canadian hospitals (10). Neonatal intensive care unit (NICU) lengths of stay (LOS) can range from several days to a few months once treatment for withdrawal has been initiated, depending upon co-morbidities and pharmacological weaning success. A recent study in Canada found a median LOS of 15 days for infants with NAS (1).

Nonpharmacologic therapy is the first-line standard of care for all opioid-exposed infants but optimal supportive therapy has not been largely studied and tends to be consensus driven as opposed to evidence-based. Supportive interventions are thought to minimize the physiological effects of withdrawal and can be used for infants who do not require pharmacotherapy or as an adjuvant to drug therapy (11). Supportive therapy may include swaddling, quiet environment, non-nutritive sucking, vestibular stimulation (rocking), and rooming-in (keeping the mother–baby dyad in hospital together) (12). Less widely adopted supportive interventions include music therapy, massage, water beds, and the use of volunteer cuddling programs (11,13–15). Although cuddler programs in NICUs across Canada are growing, none have researched program impact on infants with NAS. Only one cuddling program in the USA has produced research reporting LOS reduction for infants with NAS of 3.8 days (from an average of 26.2 days to an average of 22.4 days) (16).

Currently, there is a paucity of literature on the effectiveness of infant cuddling programs. The objective of this pilot study was to assess the feasibility and perceived impact of a volunteer cuddling program on infants with NAS from the perspective of NICU nurses and volunteers, and to evaluate the effect on LOS within a Canadian context.

METHODS

This mixed methods pilot study was conducted from October 2015 to December 2016.

Procedure

In response to the needs of infants being treated for NAS, our NICU launched a volunteer cuddling program in October 2015. The program, which utilizes trained volunteers to hold and cuddle infants to supplement during times when families are unable to be present in the NICU, was introduced as a standard of care for all infants. Parents are given the opportunity to opt-out of participation at any time during the program. Volunteers are scheduled in four hour shifts so that there is always one volunteer in the NICU 7 days a week, from 8am – 4:00pm. Volunteers were trained by an interprofessional team to recognize infant driven cues for comfort or of overstimulation. Based on the infant’s needs, the volunteers cuddle the infants in a seated or standing position, and may engage in singing, reading, or talking to the infant. If an infant is unable to be held due to medical fragility, the volunteer will hand hold the infant in the incubator.

Focus Groups

Approximately 6 months after implementation of the program, all NICU nursing staff and active volunteers in the volunteer cuddling program were invited to participate in separate focus groups. The focus groups were led by a researcher not known to participants and utilized a semi-structured interview approach. The questions used to guide the discussion in the focus groups were designed to illicit feedback for program improvement, as well as subjective experiences on the effect of volunteer interactions with both infants and their families. Each focus group lasted approximately 1 hour in duration.

Length of Stay

Retrospective data was collected on control infants with NAS between October 1, 2013 and November 20, 2015, immediately prior to the launch of the volunteer cuddling program. Prospectively, data was collected for the intervention group from November 23, 2015 to December 31, 2016. Baseline characteristics, such as gestational and maternal age, perinatal complications, and birth weight, were collected from the infant’s electronic medical record.

Inclusion criteria for the prospective cohort included prenatal maternal history of opiate use. At our hospital, opioid exposed infants remain with their mothers in the postpartum unit, rather than being directly admitted to the NICU, with mothers being encouraged to breastfeed (when not contraindicated) and to cuddle their infants skin to skin (kangaroo care) while they are being monitored for symptoms of NAS. Although not all infants with NAS are admitted to the NICU at SMH, all those with symptoms severe enough to require pharmacotherapy in the NICU (including inborn as well as transfers from other institutions), as identified by the most responsible physician, were included in this study with consent provided by their legal guardian. Infants with NAS whose mothers prenatally received buprenorphine were excluded from the study as buprenorphine was not yet a standard of care during pregnancy in Canada. LOS was used as a surrogate marker to measure cuddling impact on infants being treated for NAS, and was measured from the date of admission into the NICU until the date of discharge. Infants were discharged once they had been successfully weaned off morphine and did not require further pharmacotherapy for a period of 48 hours.

This study received ethics approval from the Research Ethics Board of St. Michael’s Hospital in Toronto, Ontario, Canada.

Data analysis

Thematic analysis of qualitative data yielded from the focus groups was conducted by two blinded coders (AH, KC) informed by grounded theory. Initial coding was conducted by one of the investigators (AH), and then coded in duplicate by a second investigator (KC) to ensure reliability in thematic interpretation. Following this, the investigative team discussed the emerging themes in an effort to better understand the program experience and considerations for program improvement to ensure sustainability.

Statistical analyses were performed using IBM SPSS statistics v 20 (SPSS Inc. Chicago, Illinois, USA). Descriptive statistics were calculated to describe the sample and for the outcome of length of stay (days) by exploring means, range, standard deviation (SD), and 95% confidence intervals (CI). Due to the large variability in the standard deviations between the control and intervention groups, the Mann-Whitney U non-parametric test was used to determine if there were differences in the distribution of length of stay between the two groups.

RESULTS

Focus Groups

All employed NICU nurses and active volunteers were invited to participate in the study. Two focus groups with nursing staff were held with a total of 10 participants, and one focus group of 6 volunteers. Standard thematic analysis of the data revealed four overall themes related to nurse and volunteer perceptions of the volunteer cuddling program. These domains were:

• 1) Staff and volunteer dynamics,

• 2) Volunteer and family dynamics,

• 3) Program operations, and

• 4) Impact of the program

Staff and volunteer dynamics

Sub-themes emerging in this domain included team cohesion (both feeling it present and absent), volunteers valuing the nursing staff, and the issue of whether nurses were reluctant or resistant to have volunteers. The focus group held with the volunteers revealed that they held high regard for the nursing staff, highlighting the professionalism and compassion of staff and indicating that they often felt a part of the team.

Family and volunteer dynamics

Volunteers and nurses echoed similar sentiments in feeling that overall the program allowed positive interaction between volunteers and families. Both groups identified that having volunteers present allowed families to take breaks and focus on self-care when needed. Further, volunteers were able to effectively engage with family members so that parents were comfortable with the program. Overall, families were appreciative of the program and valued the volunteer role.

Program operations

Volunteers and nurses provided valuable input on the structure and operations of the program. Volunteers highlighted feeling more confident in their role after having participated in the mandatory 4-hour program training, identifying the multimethod teaching approach including videos, group discussion, and low-fidelity simulation as helpful for them in setting expectations prior to the start of their cuddling role. Both groups indicated areas for the growth in the program including finding opportunities for volunteers to engage in other roles in the unit during ‘down times’ when there were no infants needing to be held, as well as requesting clarification on whether infants could/should be held while asleep. In response to this feedback, other duties in the unit were assigned to volunteers that they could engage in while not cuddling, and education was provided to staff on the benefit of infants being held while asleep.

Program impact

The final theme discussed by both nurses and volunteers was how the cuddling program had impacted them personally and how they felt infants and their families benefited. A few of the volunteers spoke about feeling sad for infants requiring intensive care but as a whole the group identified feeling fulfillment, joy, and pride in their role. Several also spoke about the benefits on their own emotional health and well-being and described their role as spiritual or meditative. The nursing group was split as all acknowledged the benefits of the program for infants whose families could not be present in the NICU and for infants with NAS, but also identified that having to be available to volunteers while they were cuddling was an added responsibility. Some of the nurses spoke to the benefit of having volunteers not just sit and hold but to also sing and do hand containment with infants not stable enough to be held out of an incubator, or to entertain siblings at the bedside to allow parents to focus on the infant. Both groups described their experiences and how cuddling helped settle the infants which in turn resulted in the need for less break through doses of morphine and facilitated better tolerance and timely pharmacological weaning.

Length of Stay All eligible participants in the prospective cohort and control group were enrolled into this study. Nine infants were enrolled in the prospective cohort (those who received consistent cuddling from volunteers). Data were collected from 14 control infants. Baseline demographics are presented in Table 1. There was no statistical difference between the groups in the variables assessed. All infants, except one in the retrospective control group and three in the prospective cohort (intervention group), had in-utero methadone exposure. Infants in the intervention group were exposed to a greater variety of other substances (see Table 2). None of the participants had any major medical complications or congenital anomalies that led to their NICU admission.

Table 1.

Baseline demographics

Variable	Control group (N=14)	Intervention group (N=9)
Gestational age (mean)	39 weeks	41 weeks + 2 days
Maternal Age (mean)	29.5 years	31.2 years
Gravida/Para (mean)	G(4), P (2)	G(3), P (1)
Delivery Mode (aggregate)	SVD=11, C/S=3	SVD=9
Birth Weight (mean)	3,036 g	2,751 g
Apgars (mean)	8.3 (1 min), 8.7 (5 min)	8.9 (1 min), 8.9 (5 min)
Nutrition source (aggregate)	Formula = 10, Breast and Formula = 4	Formula = 8, Breast and Formula = 1
SSRI/SNRI/Anti-psychotic exposure (aggregate)	Y=7, N=7	Y=4, N=4
Child welfare (aggregate)	Involvement = 14, Removal of custody = Y (9), N (5)	Involvement = 8, Removal of custody = Y (4), N (4)

Table 2.

Types of opiate exposure during pregnancy for the infants being treated for neonatal abstinence syndrome

Type of maternal opiate exposure	Group
	Control	Intervention	Total
Codeine and morphine	1 (7)	0	1 (4)
Heroin	0	2 (22)	2 (9)
Hydromorphone	1 (7)	0	1 (4)
Methadone	10 (71)	2 (22)	12 (52)
Methadone and Heroin	1 (7)	4 (44)	5 (22)
Methadone and Hydromorphone	1 (7)	0	1 (4)
Oxycontin	0	1 (11)	1 (4)
Total	14	9	23

Descriptive statistics are provided in Table 3 for the prospective cohort and the retrospective control group. The median (interquartile range) gestational age at delivery was 39.0 (36.9-39.6) weeks in the retrospective group and 37.9 (34.3-39.3) weeks in the prospective group. Time spent cuddling ranged from 10 minutes to 180 minutes (M = 78.9 minutes, SD = 39.2 minutes). Mean LOS for the control group was 30.4 days (range of 23.7 – 37.0 days) and for the intervention group was 24.0 days (range of 20.18 – 27.82 days). This was a mean LOS difference of 6.36 days (U=34, p=0.072). Visual inspection of the distribution of LOS between the two groups indicated that they were not similar.

Table 3.

Descriptive statistics for the control and intervention group

Group	Gestational age (weeks)			Length of stay (days)
	95% CI for Mean
	Mean ± SD	Min	Max	Mean ± SD	Min	Max
Control (N=14)	38.8 ± 1.5	36.7	41.6	30.36 ± 12.63	11	61
Intervention (N=9)	37.1 ± 2.8	34.0	40.7	24.00 ± 5.85	18	37

CI Confidence interval.

DISCUSSION

A volunteer cuddling program was introduced in the NICU at St. Michael’s Hospital with the intention of providing comfort to infants with NAS. The intention of this study was to illicit feedback from nurses and volunteers as to the effectiveness of this program, as well as to measure the therapeutic impact using LOS as a surrogate measure.Although the difference in LOS between the control and intervention groups did not reach statistical significance, the sample size was small and a 6-day reduction in LOS has a large clinical impact. Considering the study was conducted over 2 years, there were no significant changes in program management that could be credited for the reduction in length of stay. However, factors such as difference in types of opioid exposure, and changes in the trends in opioid use and NAS management may have influenced infant length of stay.

The main study limitations included incongruence of the type of opioid exposure between the two groups, and wide variability in the amount of cuddling each infant received. To address this, a multi-centre comparison study including sites without a volunteer cuddling program would be necessary to assess if the trend noted in this study would reach statistical significance.

NICU nurses and volunteers described benefits of program participation for infants experiencing NAS and also provided valuable insight towards volunteer cuddling programs’ sustainability. The 100% recruitment experience did confirm our assumption that parents and guardians of infants diagnosed with NAS would be open to receiving additional support through a volunteer cuddling program. In the scenario where child welfare was the legal guardian of the infant, all child welfare agencies approached for consent were receptive to participation in the volunteer cuddling program.

In Canada, the nature of NAS is changing with mothers using readily available street fentanyl and carfentanil (21). In our centre, we have observed infants demonstrating withdrawal symptoms from fentanyl/carfentanil several hours to days after birth, with later symptoms from the methadone or buprenorphine. NAS is evolving in Canada along with the nature of illicit substance use. Novel strategies to reduce severity and LOS associated with pharmacologically-treated NAS will be required. As more NICUs continue to add volunteer cuddling programs of their own, future research can involve multiple sites across Canada to build on the Canadian experience in an acute care NICU. Focus group data provided valuable insight into program sustainability, however future research should include parental and/or guardian perceptions to gain a more holistic appreciation of the program’s impact.