Participants - Parents
Fifty-four parents registered interest, of whom 38 were interviewed (Figure 1). Two PICU parents were interviewed but not included in the analysis due to recording equipment failure. Data saturation was reached both within and across the NNU and PICU samples. Our final sample of 31 included 17 NNU and 14 PICU parents including 22 mothers (12 NNU, 10 PICU; 4 were bereaved) and nine fathers (5 NNU, 4 PICU; 1 bereaved). Interviews took place between May and November 2018. Seventeen NNU parent interviews related to 19 children (Table 1) and 21 different hospitals. Three mothers had twins who were both admitted to NNU and one set of parents were interviewed separately regarding the same child. Fourteen PICU parent interviews related to ten children, with four sets of parents interviewed separately regarding the same child. Six of the ten children had also been admitted to NNU at birth and five had had multiple PICU admissions. Interviews took place on average (mode) 11 months (range=0.8-37 months) from hospital admission and took on average 68 (SD=12.7) minutes. Interviews took place between May and November 2018.
Table 1: Child characteristics and NNU/ PICU admission information based on parent interview accounts
Characteristics
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NNU
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PICU
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Child age at hospital admission (or birth)
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Median 29 weeks gestation
(range: 24- 41 weeks)
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Median 8 months old
(range 3 weeks- 12 years)
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Days in Unit
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Median 21
(range: 1- 140, missing n=1)
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Median 8 (range 2- 72)
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Days in hospital
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Median 57 (range: 7- 152)
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Median 39 (range 3- 196)
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Days on feeding tube
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Median 58 (range: 2- 210)
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Median 127.5 (range: 5- 547)
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Days on breathing support
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Median 56 (range: 0- 370)
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Median 6 days (range 0- 168)
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Main reason for admittance
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Prematurity (n=18)
Meconium aspiration syndrome (n=1)
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Heart conditions e.g. congenital heart defect, Hyperplastic left heart (n= 4)
Sepsis (n= 2)
Reconstruction of airway (n= 1) Complications linked to chronic conditions e.g. Holoprosencephaly, Noonan’s syndrome, prematurity (n= 3)
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[Insert Figure 1 Parent Recruitment]
Participants- practitioners
Fifty-one practitioners took part in either a focus group or interview. Five focus groups were conducted at three UK hospitals, this included two in NNU and three in PICU. Forty-two practitioners (16 NNU, 26 PICU) participated in one of the five focus groups. Sixty-two percent (26/42, 62%) of focus group participants were clinical nurses. The remainder were research nurses (5/42, 12%), senior doctors (3/42, 7%), dietitians (2/42, 5%). Six participants (6/42, 14%) categorised themselves as ‘other’. Three were student nurses, three did not specify.
As the majority of focus group participants were nursing staff, we purposively contacted ten consultant level doctors’ doctors, three surgeons, and five dietitians and invited them to take part in a telephone interview. Five additional dietitians expressed interest in being interviewed after receiving study information through their professional networks. Of those we directly targeted, 12/21 (58%) did not respond. A total of nine interviews were conducted including three consultant doctors (2 NNU, 1 PICU), four dietitians (1 NNU, 3 PICU) and two surgeons (both surgeons worked with NNU and PICU patients).
Ten UK hospitals were represented in the combined interview and focus group sample. The majority had experience of conducting paediatric clinical trials (39/51, 76%). Focus groups took on average 55 minutes (range 49-68 minutes) and telephone interviews 32 minutes (range 26-45 minutes).
Parents’ views on GRV measurement and feeding
Interviews began with a discussion of parents’ NNU/PICU experience, including how they prioritised feeding as a component of critical care and their knowledge of GRV. Twenty-one parents (68%) recalled their child’s GRV being measured (15 NNU, 6 PICU). Those who did recall GRV being measured had varying understanding of its utility:
“I remember quite a few occasions where they were, erm, sort of like take it out, work it out if there was too much left then they wouldn’t do the next one as much. (P21, Mother, PICU)
Parent’s views around GRV measurement appeared to be linked to their views on the importance of feeding in the ICU, their child’s prognosis and associated comorbidities or complications. For example, parents of children who experienced an imminently life-threating condition, such as sepsis, had not considered feeding to be a priority in the ICU:
“Well initially obviously they were trying to keep her alive” (P24, mother, PICU).
In contrast, parents of premature children or those with chronic conditions, such as a congenital heart defect, viewed feeding as very important. Weight gain and calorie intake were seen to have direct causal relationship with short and longer-term outcomes:
“We knew that gaining weight was central to them going home and we also knew that the greater their weight, the less risk there was of an infection.” (P05, father, NNU)
Parents described how they were initially unaware of how difficult, yet important, establishing feeds was at the beginning of their NNU stay and would still be in what feels like an acute situation:
“I remember them saying, oh, they’ve coped really well with the last feed, and you think, coped really well? How hard is eating? And they don’t explain to you that it can have a huge a huge impact” (P11, mother, NNU).
Over half of the PICU parents had past NNU experience and therefore had already developed views on feeding in the early phase of their PICU stay, which would be the point at which parents would be approached to discuss their child’s participation in the proposed trial.
Potential benefits and concerns about conducting the proposed GASTRIC Randomised Control Trial
Parents and practitioners were asked to consider the proposed trial. Practitioners identified some potential benefits of not measuring GRV such as reduced reliance on intravenous lines and less problems with gut motility. Both parents and practitioners described how not measuring GRV might be beneficial because it might increase nutritional intake and remove a potentially unnecessary and “quite invasive” (P03, mother, NNU) intervention that may increase the: “risk of infection” (P03, FG3, nurse, PICU). However, as Table 2 shows, 88% of practitioners felt that there would be barriers to staff not measuring GRV in the proposed trial.
Table 2: Practitioner views on ‘Do you think there will be any barriers to staff not measuring GRV?’ in a proposed trial by role (N=48)
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Senior nurse
(n=11)
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Junior nurse
(n=15)
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Research nurse
(n=4)
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Senior doctor
(n=7)
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Dietitian
(n=7)
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Other
(n=4)
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Total
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Yes
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9 (21%)
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14 (33%)
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4 (10%)
|
5 (12%)
|
6 (14%)
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4 (10%)
|
42 (88)
|
No
|
2 (33%)
|
1 (17%)
|
0 (0%)
|
2 (33%)
|
1 (17%)
|
0 (0%)
|
6 (12)
|
Practitioners and parents voiced concerns about how not measuring GRV may delay the diagnosis of bowel or stomach problems, infection, NEC, or lead to incorrect feeding tube placement or feed intolerance:
“You'll have a baby who you're not measuring residuals anymore, who will end up with NEC and then they'll say oh this would have been picked up earlier if we'd realised it has bilious aspects.” (P05, FG5, consultant neonatologist, NNU)
Nevertheless, half of the practitioner sample (mainly doctors) interviewed also described how they:
“don't think that measuring the GRV is going to be a, um, reliable indicator of whether a baby's got NEC or is at risk of getting NEC” (P05, interview, surgeon).
With others stating that measuring GRV was, on its own: “completely meaningless” (P06, interview, doctor, NNU) and that:
“Babies who are gonna develop an important pathology, never present purely with gastric residuals” (P06, interview, doctor, NNU).
Other concerns, such as not detecting incorrect tube placement, or not being able to wind a child, were addressed by researcher clarification that children would still have routine gastric aspirates assessed for tube position (but not assessed for gastric residual volumes) in line with existing guidance.
Parents and practitioners were also worried about the risk of vomiting into lungs leading to possible chest infections and breathing difficulties. Interestingly, some suggested contrasting views in that both measuring and not measuring GRV may lead to vomiting, or cause pain and discomfort. Whilst some parents and practitioners were concerned that returning stomach contents may cause a child to vomit: “nine times out of ten if they shot it back in she was sick.” (P15, NNU, father) or cause pain or discomfort. Others felt that not measuring GRV may result in discomfort and vomiting.
The challenge of changing routine clinical practice
Almost half the practitioners, unprompted, 23/51 (45%) discussed the potential difficulty of changing such an accepted and embedded routine practice for a clinical trial:
“I can imagine there will be barriers to it because it’s just the way that things are done” (P02, interview, dietitian, PICU).
Nurses, in particular, valued GRV measurement as a useful common practice that they perceived informed patient care. Six participants, from a range of clinical backgrounds, described how they would “feel uncomfortable” (P06, FG3, senior nurse, PICU) about changing this ‘normal’ practice for a trial: “without the evidence” (P07, FG2, research nurse, PICU) to support such a change. Others stated that while they would personally participate in the proposed trial, they felt that their colleagues may not be willing to change their behaviour:
“If the surgeons are involved, they'll want to know what aspirates are and the amount as well” (P05, FG1, nurse, NICU).
Some dietitians stated that they were planning to change their practice to not measure GRV, which meant the proposed trial was less of a concern to them. Suggestions included the need for bespoke site training to assist engagement and behaviour change, including additional information to support the study rationale, including evidence to:
“demonstrate why not measuring GRVs would be a sensible thing to do and in fact might be beneficial” (P05, interview, surgeon).
Overall views on the acceptability of the proposed GASTRIC Randomised Control Trial
Parents and practitioners were asked to reflect and consider the acceptability of the proposed trial. Despite the concerns identified, the majority (39/46, 85%, 5 missing) of practitioners indicated it would be acceptable ‘to conduct the proposed trial’. Only 15% (7/46) said it was not acceptable to conduct. Of these seven, six were junior nurses. Parents also supported the proposed trial, with 90% (28/31) stating that they would provide consent for their child to take part. This acceptability was underpinned by a belief that the proposed study question: “makes perfect sense” (P23, father, PICU). Overall both groups viewed the proposed ‘measuring GRV arm’ acceptable because it is a useful standard practice. For the parents, hospitals would: “Just carrying on doing what we're doing anyway” (P20, mother, PICU). There was some ambivalence amongst clinical staff about the importance of the proposed trial. Four doctors and one surgeon reflected that GRV measurement was not a: “big issue” (P06, interview, doctor, NNU) or not important: “in the grand scheme of things” (P07, interview, doctor, PICU).
Parents with experience of tube feeding at the point of their child’s intensive care admittance (n=11) appeared to have a trial arm preference. However, the trial arm (GRV or No GRV) they preferred varied. Although many stated that their preference would not prevent them from consenting to the trial, they would require detailed information about the potential risks and benefits of each trial arm to reach a consent decision. Conversely, parents with no pre-existing knowledge or beliefs about tube feeding viewed GRV measurement/ no measurement as of little importance. This view point was potentially influenced by their view that feeding was a low priority during a critical care situation. These parents described how their child’s acute condition was the main priority and a trial involving measuring or not measuring GRV would be therefore of low risk and therefore acceptable:
“I think that would be the last thing on me mind. So no, it wouldn't bother me.” (P27, mother, PICU & NNU).