Skin-to-skin contact initiation and duration

The Fischer SCRIP score

Variable Score

2 1 0

(A) Heart rate Regular Deceleration of heart rate

>80 bpm <100 bpm Bradycardia <80 bpm and/or tachycardia >220 bpm = 1 min in quiet sleep

(B) Respiration Regular Apnoea <10 s and/or periodic breathing (=apnoea >3 s, regular respiration <20 s at least 3 times)

Apnoea > 10 s and/or

tachyponea >80 bpm = 1 min in quiet sleep

(C) Oxygen saturation (pulse oximetry)

Regular

>90% Falls <90% >80% Falls <80%

Table 7: The Fischer SCRIP score. bpm=breaths or beats per minute

The proportions of infants with any CPAP in the iKMC and control groups of study V were 62% and 60%, respectively. In those infants who did have CPAP, median time with CPAP was 32 hours (IQR 12-66) in the iKMC group and 28 hours (IQR 11-59) in the control group.

The difference in duration was 6.6 hours after adjustments, (95% CI 1.64-11.6), p= 0.009, in favour of the control group. To our knowledge, there are no previous studies reporting on the duration of respiratory support in SSC. CPAP machines were variably available at the sites before but were introduced prior to study launch on the initiative of the WHO as part of the introduction of a minimal package of newborn care and to standardise the care between sites.

Interestingly, there were site differences in terms of use of CPAP. The sites in Malawi and Tanzania had lower proportions of infants with CPAP, at 55% and 48%, respectively. In Ghana the proportion of infants with CPAP was higher, at 71%. The differences in CPAP duration between allocations may be explained by actual different needs of the infants or by confounding by indication.

Median times to clinical stabilisation, i.e. times to meeting the pre-specified stabilisation criteria listed in section 3.4.4, were similar between allocations at 73.8 hours (IQR 26.8-138.5) in the intervention group and 74.8 hours (IQR 25.3-140.6) in the control group. To our knowledge, there are no previous studies describing the time until stabilisation in immediate SSC.

three days and first seven days were 0 (IQR 0-2), 1.7 (IQR 0-3.7), 2.4 (IQR 0.9-4.4) and 4.9 (IQR 3.3-6.7) hours, respectively.

Skin-to-skin contact on the first postnatal day by gestational week in study III Gestational week Any SSC on the first day,

n (%) SSC duration first day in infants who received SSC, median (IQR)

22 1/39 (2.6) 1.5

23 3/65 (4.6) 1 (1-3)

24 2/78 (2.6) 1 (1-1)

25 4/101 (4.0) 1.9 (1.6-2)

26 5/112 (4.5) 2.3 (2-3)

27 12/144 (8.3) 2.8 (1.8-8.5)

28 21/155 (14) 2.6 (1.8-8.5)

29 55/209 (26) 2.5 (1.5-5)

30 105/255 (41) 3 (2-5)

31 135/317 (43) 3 (1.5-5.5)

Table 8: Proportion of infants with any SSC and median SSC duration during the first postnatal day by gestational week. SSC=skin-to-skin contact, IQR=interquartile range.

Figure 3: Time to first SSC in VPT infants by region in study III. East (Stockholm); n=103, West (Gothenburg); n=86, South-East (Linköping); n=49. North (Umeå); n=45, South (Lund); n=90, Middle (Uppsala); n=94

In the light of challenges to randomise away from SSC in study II, motivated by immediate SSC being a part of the conventional care, the results from the register study indicated the opposite; that SSC initiated immediately after birth was not part of the conventional care of

0.000.250.500.751.00

0 24 48 72 96 120 144 168 192 216 240 264 288 312 336 360 Hours after birth

East North

West South

South-East Middle

Time to first SSC in VPT infants

VPT infants in Sweden. The SSC initiation time and daily durations of SSC for VPT infants seemed to be much lower than what would have been feasible knowing the background that parents stay in the NICU with their infant around the clock. Moreover, the care claimed to be based on the IFCDC principles (68) and a large proportion of infants were cared for in units either affiliated to a NIDCAP centre or to a unit with a SSC profile where professionals teach about the benefits of SSC.

Since all EPT and VPT infants were provided care in NICUs and all NICUs report to the SNQ, the register data was population based. However, register data relied on that NICU staff documented the SSC in the patient file. Since the absence of SSC is not documented, only the duration of any SSC, it was impossible to discriminate between no SSC provided and missing data. Validation of the data was discussed, but unfortunately this was not possible. During the same time period, SSC durations had not been collected on a large scale for any other purpose but for the SNQ. According to the preliminary results of study II (n=91), the median daily SSC duration during NICU stay was 6.7 hours. This cohort from Stockholm was constituted of infants with parents who had consented to participation in a trial investigating the effects of immediate SSC, probably making them more motivated for long durations of SSC. Hence, a median daily duration of SSC of 4.9 hours may be representative for VPT infants in a Swedish NICU.

KMC involves early and continuous SSC, but most studies referred to in the introduction either do not report on duration or report effects of a couple of hours of SSC daily only.

Studies reporting on dose-response effects of SSC are scarce. In HICs, SSC is usually delivered intermittently and total time per day varies between settings, families and also between units (164). In Europe, polices for parents in the NICU have changed over the past two decades and parental presence has increased (165). In addition to parental policies, benefit systems (154) also have an impact on parents’ opportunities to participate in the care of their preterm infant and for SSC.

A Swedish population-based study from 2012 involving EPT infants, reported a median SSC initiation time at six days after birth (166). In study III, the median SSC initiation time for EPT infants was shorter, at 3.5 postnatal days. Concerns of early SSC involve a potentially stressful transfer of the infant from the incubator to the parent and fear of heat and fluid loss.

These factors may delay the SSC initiation time. However, one study has described that SSC during the first postnatal week is feasible for EPT infants (140). In VPT infants, SSC was started earlier, at six hours, concluding from a report from two Swedish NICUS during the same time period (167). This was an earlier initiation time than our finding in study III.

Parents’ continuous presence in the NICU was variably encouraged across settings and depended on parental leave systems and ward structures and routines, according to another report (168). NICUs may also have different criteria for when SSC is considered safe. A European study showed that the daily dose of SSC varied between countries, and a NICU in Sweden was in the lead with a mean SSC duration of eight hours per day (169), for

moderately preterm infants. Policies regarding family presence in the NICU also varied greatly in Europe (165). The regional differences in SSC initiation time and daily duration in study III confirm that regional guidelines and traditions have a large impact on what

opportunity preterm infants have to SSC with their parents.

In study IV, SSC initiation time in the iKMC group was 1.3 hours. The median daily duration of SSC during the first three postnatal days was very high at 17 hours in the iKMC group, compared to 1.5 hours in the control group. This is a very long median SSC duration compared to the studies mentioned above. Dose-response analyses were not possible in this study, because of reversed causality where well infants had the opportunity of long SSC durations and sicker infants less so due to their need of medical interventions.