Efficacy of gavage feeding in KMC position Vs supine position in preterm and low-Birth-weight newborns (less then 1500 g) In reducing feed intolerance: A randomized Control trial

1. Brief summary of intended work:

1.1   Need for the study:

Feeding intolerance (FI) is a common problem among preterm / low-birth-weight (LBW) infants due to immature gastrointestinal function and increased susceptibility to complications such as necrotizing enterocolitis (NEC) [1]. The clinical definition of FI varies across studies, but it is commonly identified by increased gastric residuals, abdominal distension, and vomiting [2]. These complications delay the establishment of full enteral feeds, prolong parenteral nutrition, and adversely affect growth and clinical outcomes.

Gavage feeding is frequently required in preterm / LBW infants who are unable to coordinate suck, swallow, and breathing reflexes and those who are seek [3]. During gavage feeding, milk is administered through a tube inserted orally or nasally into the stomach, typically while the infant lies supine in a crib or under a radiant warmer. Studies have explored various feeding techniques, including gravity-assisted, syringe pump-assisted, bolus, intermittent, and continuous methods; however, consensus on the optimal approach remains lacking. Feeding duration varies from 10 to 30 minutes or more, and both the rate of infusion and infant position may influence feeding tolerance through mechanisms such as altered gastric emptying, aspiration risk, or cardiorespiratory instability [4,5].

National and international guidelines endorse Kangaroo Mother Care (KMC) as a standard practice for stable LBW infants. KMC has been shown to enhance thermoregulation, breastfeeding outcomes, infection control, and mother–infant bonding [6]. Physiological proximity during KMC may also improve gastrointestinal motility and feeding tolerance compared with standard supine positioning [7]. However, despite KMC’s well-documented benefits, its integration into feeding routines remains limited, particularly in resource-constrained settings [8].

Our neonatal unit often practices syringe pump-assisted gavage feeding over one hour while infants are in the KMC position (GF KMC) . In KMC, the infant lies prone on the caregiver’s chest in skin-to-skin contact [9]. The World Health Organization recommends that gavage feeding can be safely provided during KMC [9]. Evidence suggests that prone positioning reduces gastric residuals, a surrogate marker for feeding tolerance, yet literature on feeding during KMC remains scarce [10].

Therefore, this study aims to compare Gavage Feeding in KMC position (GF KMC) versus Gavage Feeding in Supine position (GF Supine) to assess feeding intolerance among LBW infants.

1.2   Review of literature

Feeding intolerance is a frequent clinical concern in preterm infants, reflecting their inability to tolerate enteral nutrition. It manifests as increased gastric residual volumes (GRV), abdominal distension, vomiting, or blood in stool, leading to interruption of feeds. However, definitions and diagnostic criteria vary widely across studies, complicating interpretation and comparison [11]. Meta-analyses estimate the prevalence of FI between 15–30%, with a pooled rate of approximately 27%.

Gavage feeding is essential in LBW infants who cannot coordinate oral feeding. Modes of delivery—intermittent bolus or continuous infusion—have distinct physiological effects. Studies show that slow intermittent feeding over one hour using a syringe pump enhances adult like- duodenal motor response, improves gastric emptying, stabilizes hormonal responses, and improves tolerance compared with rapid bolus or continuous methods [12,13]. Moreover, Continuous feeding results in less insulin and amino acid hormonal surges, which diminishes protein synthesis compared to intermittent bolus feeding [13].

Atay et al. compared slow infusion intermittent feeding (SIF) using a syringe pump (1 hour) with gravity-fed intermittent bolus feeding (IBF) in preterm infants (24–31+6 weeks). The SIF group had significantly fewer FI episodes, shorter nil per oral (NPO) durations, and faster weight regain, highlighting the benefits of controlled, slow infusion feeding [14]. Similarly, Kumar V et al. found no major differences in time to full feeding or growth between continuous, intermittent infusion, and gravity bolus groups but emphasized that pump-assisted feeding ensures better timing control [15].

Fanaro et al. on feeding intolerance highlights that slow infusion improves duodenal motility and gastric emptying in preterm infants, which physiological studies support. Slow feeding by pump reduces feeding intolerance incidences, which is crucial in LBW infants who often experience delayed gastric emptying and immature GI function [16]. This is congruent with the RCT findings by Atay et al. and Kumar et al., where controlled timing and slow delivery of feeds using infusion pumps reduced feeding intolerance relative to gravity bolus feeding approaches.

Recent literature shows that KMC offers significant benefits for feeding tolerance in preterm infants by improving digestion, vital signs, and reducing symptoms such as gastric residual volume, vomiting, and abdominal distension, when compared to routine supine/prone positioning [9]. KMC significantly reduced episodes of FI compared to standard supine/prone care, with lower mean GRVs (KMC: 0.84 ± 3.28 ml vs. 4.17 ± 6.04 ml in supine/prone group) and fewer instances of abdominal distension or vomiting. FI was observed in only 4.8% of KMC infants versus 21.4% with standard care. But, in this study KMC was provided for 1 hour after the gavage feeding was over [17]. Continuing tube feeding while ongoing KMC has not been explored yet, however a preliminary study reported less feed intolerance with feeding the newborn prone in KMC position [7].

In recently submitted thesis at Bhaikaka University on feed intolerance by Patel DV et al, on Gravity assisted ‘bolus’ feeding over 5-10 min versus syringe pump assisted ‘slow’ intermittent gavage feeding over 30 min in preterm newborns found superiority of syringe pump assisted ‘slow’ intermittent gavage feeding over 30 min in reducing feed intolerance (18). After this study and based on the benefits of 1 h slow feeding using syringe pump from other study, 1 h slow intermittent feeding is a norm in our Neonatal Intensive Care Unit (NICU) [14,18].

To improve KMC hours, we often practice tube feeding (gavage feeding) in KMC position [9]. Prone position alone has been found to reduce feed intolerance in term of reduced GRV [10], but its use has been limited due to increased incidence of sudden infant death in isolated prone position [19], this is not the case in KMC position as KMC reduces neonatal mortality [9]. This study explores utility of KMC as a feeding position of newborn to assess incidence of feed intolerance.

2   Material and method:2.1  Source of data:

The study will be conducted in the NICU and KMC wards of Shree Krishna Hospital. Feeding practices follow national guidelines ICMR [20]. Infants unable to feed orally are given gavage feeds using syringe pumps over one hour under clinician supervision every 3 h interval, i.e. total eight times in 24 h.

2.2  Methodology:

Design: Prospective, balanced and stratified parallel-group randomized controlled trial.

Randomization and Study Procedure:

Eligible newborns will be randomized (1:1) by balanced stratification [Birth weight, and Appropriate for Gestational Age (AGA)/ Small for Gestational Age (SGA)] to either GF KMC (intervention) or GF Supine (control) using Stata v 14.2. Allocation will be concealed using sequentially numbered, opaque, sealed envelopes maintained by a nurse not involved in data collection. The statistician will remain blinded to group assignments.

In the control group, infants will receive slow gavage feeding via syringe pump over 1 h in a supine position under a radiant warmer or on bed at every 3 h interval. KMC will be practiced in this group at the time when the newborn is not receiving the gavage feeds.

In the intervention group, infants will receive slow gavage feeding via syringe pump over 1 h while in a semi-upright, prone KMC position on the caregiver’s chest as many times as possible. During rest of the times (e.g. mother / caretaker is not available / resting), gavage feeding will be given in supine position.

Study end points: Data will be collected until the infant starts accepting oral feeding by spoon or direct breastfeeding. Changes in feeding mode by the clinician will also be considered an endpoint. At the end point, a feasibility survey of mothers (in GF KMC group) and nurses will be carried out by the investigators. The questions in the survey are Yes/ No type and open ended.

Baseline perinatal characteristics (gestational age, birth weight, sex, delivery mode, SGA status, Apgar scores, etc.) will be documented for both groups.