Oromotor intervention as a method to improve transition from gavage to full katori spoon feeding in preterm newborns: An open label randomised control trial

Abstract

Preterm infants on gavage feeding encounter difficulties during their transition to direct oral feeds, which prolongs their hospital stay. The objectives of our study was to compare the transition time from gavage feeding to full katori spoon feeding in oromotor intervention (OMI) and control groups with feeding efficiency and milk volume transfer. An open labelled randomised control trial (RCT) was conducted. The new-born was followed up till reaching full katori spoon feeding. The mean transition time was shorter in the intervention group. Mean weight gain and mean length of stay in intervention group was improved compared to control. We concluded that OMI leads to shortened transition time to reach full katori spoon feeds and better feeding performance in the form of volume transfer and feeding efficiency.

Keywords

Disease prevention treatment birth preterm gavage feeding katori spoon feeding oromotor stimulation

Introduction

An estimated 14.9 million preterm neonates are born every year, constituting 11.1% of all live births worldwide. In India, 3.5 million preterm babies are born every year contributing to the majority worldwide.^1–3 Neonatal intensive care advances have dramatically improved the survival of preterm infants leading to later difficulties in oral feeding in an estimated 30-40% of cases.^4,5 Oral feeding is a complex skill that requires the newborn to coordinate the muscles of the jaw, lips, tongue and cheeks for motor stability.^6–12

Oral and gag reflexes are well developed at 12 to 16 weeks of gestation. However, a fully coordinated suck-swallow-breathe pattern usually develops after 34 weeks of gestation as the central nervous system matures.^13–19 Therefore, before reaching maturity for independent oral feeding, preterm neonates require gavage feeding.^20–26

Oromotor intervention (OMI) is defined as sensory stimulation of lips, jaw, tongue, soft palate, pharynx, larynx and respiratory muscles, which results in physiological underpinning of oro-pharyngeal mechanisms enhancing their function.^27–32 Non-nutritive sucking (NNS) and kangaroo mother care (KMC) are now a part of routine care of preterm neonates. However, despite several advantages of OMI, it is not yet accepted as a standard of care. A Cochrane meta-analysis of 19 studies also emphasised the need for further studies to understand better the benefits and harms of OMI in preterm neonates.^14,31 Only two studies were found in the literature where OMI was compared with KMC and NNS as routine care in the control group.^25,28 Hence this study was planned.

Materials and methods

Our study was conducted in the Neonatal Intensive Care Unit (NICU), Department of Paediatrics, Guru Gobind Singh Medical College and Hospital, Faridkot from March 2021 to January 2022. The study was an open-label randomised control trial (RCT).

All consecutive preterm neonates with a gestational age (GA) of ≤32 weeks admitted in the NICU formed the study population. The intervention group consisted of 35 preterm neonates who received pre-feeding OMI along with KMC and NNS. The control group consisted of 35 preterm neonates who received only KMC and NNS.

Included were inborn preterm neonates with GA ≤ 32 weeks, with weight appropriate for their GA, who had reached full gavage feedings (120 ml/kg/day) and were haemodynamically stable, needing no inotropic nor respiratory support.

Excluded were large or small for their gestational age (LGA and SGA, respectively); those with medical complications such as grade 3 or 4 intraventricular haemorrhage, periventricular leucomalacia, necrotising enterocolitis and bronchopulmonary dysplasia, as well as those with haemodynamic instability (needing inotropic or respiratory support), and those with congenital malformations such as complex heart disease and oral and gut malformations.

Considering hospital statistics, a convenient sample of 70 preterm neonates, 35 in each group was included; no formal power calculation was undertaken.

The subjects were randomly allocated into the intervention or control group using computer-generated random numbers after obtaining informed written consent from the investigator not directly involved in the study. We followed a parallel group design and block randomisation was done with variable block sizes (2–8). Sequentially numbered opaque sealed envelopes were used for allocation concealment.

Oromotor intervention

Pre-feeding OMI was provided by stroking the cheeks, lips and tongue and rubbing the gums over five minutes as performed in two earlier studies.^14,31

Methods

The intervention group received routine care, that is, KMC for 3–4 hours/day and NNS before each feed. OMI was also given to these neonates 5 times/day by the principal investigator and three trained MSc nursing staff. The routine gavage and katori (katori is a small steel bowl which is a part of most table settings in Indian households) spoon feeding was given by on-duty nurses who were blinded to the groups and recorded the duration and volume of feed in every observed feeding session. The katori spoon feeding was advanced according to the oral feeding advancement protocol shown in Table 1. The feeding efficiency (after each OMI session) was assessed longitudinally when the neonates were able to take 2, 4, 6 and 8 successful oral feeds. They were followed up till they reached full katori spoon feeding. The transition time was calculated from the day of the start of orogastric feed to full katori spoon feeding. Weight was recorded daily, head circumference weekly and length at birth and discharge. The preterm neonates in the control group were managed in the same manner except that they did not receive OMI.

Table 1.

Transition time from full gavage to full katori spoon feeding in the intervention and control groups.

Variable	Groups		p-Value
Variable	Intervention (n = 35) (mean ± SD)	Control (n = 35) (mean ± SD)	p-Value	95% CI
Transition time from full gavage to full Katori spoon feeding (days)	6.77 ± 2.87	9.14 ± 3.26	0.002	−0.38, −0.9

Data were described in terms of range; mean ± standard deviation (±SD), frequencies (number of cases) and relative frequencies (percentages) as appropriate. To determine whether the data were normally distributed, a Kolmogorov–Smirnov test was used. Comparison of quantitative variables between the study groups was done using the Student’s t-test and Mann–Whitney U test for independent samples for parametric and non-parametric data, respectively. For comparing categorical data, the χ² test was performed and the exact test was used when the expected frequency was <5. Kaplan–Meier estimates of survival were performed and compared using the log-rank test. A p-value <0.05 was considered statistically significant. All statistical calculations were done using Statistical Package for the Social Science 21 version (SPSS Inc., Chicago, IL, USA) statistical programme for Microsoft Windows.

Ethical considerations

Approval was obtained from the Thesis Committee of the institution. The trial is registered under the Clinical Trial Registry after approval from the ethical committee with trial number: CTRI/2021/03/032111 dated 18/3/21.

Results and observations

During the study period, a total of 484 preterm neonates were admitted, out of whom 208 had GA ≤ 32 weeks. Among these, 138 were excluded. The main reasons for exclusion were LGA (n = 20) and SGA (n = 48). Other reasons for exclusion are shown in Figure 1. Finally, a total of 70 neonates were included. They were randomly allocated into two equal groups. All the 70 neonates were finally analysed. Figure 1 shows the trial flow. Table 2 shows the demographic profile of the two study groups.

Table 2.

Demographic data of the study population.

Variables	Groups		p-Value
	Intervention (n = 35)	Control (n = 35)	p-Value	95% CI
Sex {n, (%)}
Male	22 (62.9)	16 (45.7)	0.2 (NS)
Female	13 (37.1)	19 (54.3)
Birth weight (g) (mean ± SD)	1585.00 ± 229.34	1524.57±224.23	0.3 (NS)	−47.6,168.6
GA (weeks) (mean ± SD)	31.70 ± 1.01	31.31 ± 1.17	0.1 (NS)	−0.55,0.49
Antepartum Haemorrage {n, (%)}	6 (17.1)	4 (11.4)	0.5 (NS)
Pre-eclampsia/eclampsia/Pregnancy induced Hypertension {n, (%)}	19 (54.3)	14 (40.0)	0.2 (NS)
Chronic medical illness {n, (%)}	6.74 ± 0.98	6.77 ± 1.19	0.9 (NS)
Premature Rupture of Membranes > 24 h (n, %)	8.34 ± 0.73	8.23 ± 0.91	0.5 (NS)
Antenatal steroid exposure {n(%)}	17 (48.5)	21 (60.0)	0.3 (NS)
Hyaline Membrane Disease {n, (%)}	1 (2.)	2 (5.7)	0.5 (NS)
Clinical sepsis {n, (%)}	7 (20.0)	5 (14.2)	0.5 (NS)
Culture positive sepsis {n, (%)}	2 (5.7)	3 (8.5)	0.6 (NS)
Continuous Positive Airway Pressure	21 (60.0)	22 (62.8)	0.8 (NS)
Invasive ventilation	5 (14.28)	4 (11.4)	0.7 (NS)
Non-invasive ventilation	6 (17.14)	9 (25.7)	0.4 (NS)
No support	3 (8.5)	0 (0.0)	0.1 (NS)

Figure 2 shows the transition time in both groups. The intervention group mean transition time was shorter than the control with a highly significant difference with the former having 2.37 days shorter transition time than the control group (p = 0.00).

Table 3 shows the feeding efficiency of intervention and control groups at 2, 4, 6 and 8 successful oral feeds. Feeding efficiency at two successful oral feeds was 0.72 ± 0.19 ml/min in the intervention group and 0.61 ± 0.20 ml/min in the control group (p = 0.024). Feeding efficiency was significantly higher in the intervention group than control group at all feeding milestones. Table 4 shows the daily weight gain rate (g/kg/day) of neonates during the study period in intervention and control groups. The difference was not statistically significant (p = 0.986). The length of hospital stay was shorter in the intervention group than in the control group, but statistically insignificant.

Table 3.

Feeding efficiency at 2, 4, 6 and 8 successful oral feeds in the intervention and control groups.

Feeding efficiency (ml/min)	Groups		p-Value
Feeding efficiency (ml/min)	Intervention (n = 35) (mean ± SD)	Control (n = 35) (mean ± SD)	p-Value	95% CI
At 2 successful oral feeds	0.72 ± 0.19	0.61 ± 0.20	0.024	0.02,0.2
At 4 successful oral feeds	0.79 ± 0.20	0.68 ± 0.18	0.012	0.03,0.21
At 6 successful oral feeds	0.89 ± 0.23	0.76 ± 0.19	0.013	0.03,0.2
At 8 successful oral feeds	1.01 ± 0.21	0.79 ± 0.20	<0.001	0.21,0.32

Table 4.

Weight gain rate and length of hospital stay of newborns in the intervention and control groups.

Variable	Groups		p-Value	95% CI
Variable	Intervention (n = 35) (median/IQR	Control (n = 35) (median/IQR)	p-Value
Weight gain rate (g/kg/day)	3.78/8.36–5.43	−5.38 to 4.36	0.986 (NS)	−5.30, 5.21
Length of hospital stay(days)	10/9–19	15/10–20	0.612 (NS)	−7.31, 4.33

Discussion

Preterm neonates have significant morbidity secondary to delay in initiation and reaching full feeding orally due to lack of coordination between suck swallow breathing. Our study showed that the intervention group reached full feeding early as compared to the control group after receiving OMI along with NNS and KMC and the results were statistically significant. It is probable that the OMI will lead to better survival in terms of rapid weight gain.

OMI can lead to a reduction in hospital stay thereby reducing the cost of treatment.^2,3,7,18,32

A wide variation in reaching the mean time to full feeding is seen owing to the use of different feeding protocols by the authors as in most of the studies feeding advancement was at the discretion of the attending neonatologist.

We studied feeding efficiency for eight successful feeds and efficiency increased from 0.75 ml/min to 1 ml/min in the intervention group which is significantly higher than the control group. The mean feeding efficiency and mean volume transferred were significantly increased after OMI in the intervention group. As in other studies,^10,25 we have shown steady weight gain at different feeding milestones. We practiced NNS and KMC in all the patients which was not done in most of the previous studies. We also used a katori spoon as the method of feeding in contrast to bottle feeding used in previous studies.

Blinding could not be done owing to the nature and introduction of oral feeding techniques. The readings were cross checked amongst the team members, the PI and MSc staff to maintain the quality of data. The behavioural state of neonates was not monitored before and after the intervention

We conducted an open-label RCT on the novel subject which helps in rapid advancement in the feeding of preterm neonates which is usually difficult to establish. We compared all factors like KMC and NNS along with OMI in establishing the full Katori feeding.

We conducted a single-centre study with a relatively small sample size and we did not include SGA, LGA and intrauterine growth-restricted newborn babies.

Conclusion

We demonstrated that administration of OMI in preterm neonates on full gavage feeding leads to shorter transition time to reach full katori spoon feeds with better oral feeding performance in the form of volume transfer and feeding efficiency. Further studies are needed on the timing of the introduction of OMI for optimal feeding in all types of preterm neonates.

Footnotes

Authors’ contributions

Dr Sakshi Jindal conceptualised, coordinated and supervised data.

Dr Seema Rai conceptualised and designed the study, drafted the initial manuscript and reviewed and revised the manuscript.

Dr Amanpreet Singh did editing and proof reading.

Dr Gurmeet Kaur did editing, statistics and reviewed and revised the manuscript.

All authors approved the final manuscript as submitted and agree to be accountable for all aspects of the work. The trial is registered under Clinical Trial Registry after approval from the ethical committee with trial number: CTRI/2021/03/032111 dated 18/3/21.

Declaration of conflicting interests

The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The authors received no financial support for the research, authorship, and/or publication of this article.

ORCID iDs

Seema Rai

Amanpreet Singh

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