Early Human Development 54 (1999) 29–38

A controlled trial of alternative methods of oralfeeding in neonates

a a bNidhi Malhotra , Leela Vishwambaran , K.R. Sundaram ,a ,*Indira Narayanan

aDepartment of Pediatrics, Moolchand Hospital, New Delhi, India

bDepartment of Biostatistics, AIIMS, New Delhi, India.

Received 27 May 1998; received in revised form 28 August 1998; accepted 1 September 1998

Abstract

Background: Some neonatal units are introducing use of cup and traditional feeding devicesfor feeding young infants although they have been not been evaluated objectively. Hence thiscontrolled trial of the use of the bottle, cup and a traditional feeding device (‘paladai’) wasundertaken in neonates. Method: The study comprised of 100 infants including full-termnormal weight infants (n 5 66), term growth retarded infants (n 5 20), and preterm infants(n 5 14). All three methods were tried on every infant by the same nurse for a particular baby,so that each infant served as his /her control and in order to avoid the effect of majorinfluencing factors. Parameters evaluated were the volume ingested, duration of the feed,degree of spilling and satiety. Results: The infants took the maximum volume in the least timeand kept quiet longest with the paladai. The findings were particularly significant in the groupincluding all the categories of infants. Spilling was the highest with the cup, especially withpreterm infants. 1999 Elsevier Science Ireland Ltd. All rights reserved.

Keywords: Feeding devices; Bottle; Cup; Traditional feeding device (‘paladai’); India;Neonates

1. Introduction

With the wide acceptance of the importance of breastfeeding in young infants, the

*Corresponding author. E-215, East of Kailash, New Delhi 110065, India. E-mail:indiranarayanan@iname.com

0378-3782/99/$ – see front matter 1999 Elsevier Science Ireland Ltd. All rights reserved.PI I : S0378-3782( 98 )00082-6

30 N. Malhotra et al. / Early Human Development 54 (1999) 29 –38

emphasis is now not only on methods for its promotion but also on the avoidance ofinappropriate, detrimental factors [1]. The value of human milk in high risk infantshas been clearly documented in several controlled studies [2–4]. Bottle feeding anduse of pacifiers are likely to interfere with breastfeeding and there is evidence to showthat the method of sucking on the bottle nipple and the breast nipple are different [5].Hence even when non-nutritive sucking is initiated in preterm infants it might bebetter to use, wherever possible, the ‘emptied’ breast for this purpose rather than apacifier [6].

In recent years, interest has been centered on alternative methods of feeding suchas the use of spoons, cups and traditional feeding devices [7–9]. Reports, however,have been primarily description of experiences in a unit and findings in older infants.These items are also being used in several units in different parts of the world withoutany objective evaluation. Hence, this prospective controlled study was undertaken onsuch methods of feeding high risk neonates including preterm and low birthweightinfants. As an earlier evaluation of spoon feeding carried out in infants under 6months of age showed that it was time consuming and associated with significantspilling [8], it was not included in the present study. The items evaluated were thebottle, cup, and a traditional feeding device (‘paladai’) used in some of Indiancommunities [7]. Most traditional feeding devices resemble one of two prototypes[10]. One resembles a small teapot with a long narrow spout which was felt to beinappropriate as it was not only difficult to clean and sterilize but evaluation of thecleanliness was not possible as the inside of the spout was difficult to visualize. Thesecond is a cup-like device with an open projection (Fig. 1). It is called ‘paladai’ insome of the South Indian communities [7]. This item is also similar to the ‘pap boats’used in the past in some Western countries [11]. It was chosen as it is economical,easy to clean, and familiar to many traditional communities.

2. Material and methods

This study was undertaken on babies who were admitted to the nursery for specialcare and on some of the normal babies kept in the nursery for maternal problems.

As these feeding utensils, especially, the bottle and the paladai, were already in usein the unit, as well as in some other hospitals in the country, the nurses were told touse them in the manner that they were already accustomed to and each feed wasmonitored by a single person (N.M.). In the pretest phase, babies were allocated tothree different groups, bottle feeding, use of a cup and the ‘paladai’. This, however,was noted to have inherent problems as results were easily influenced by the infants’gestation age, weight, postnatal age, presence of illnesses and their severity, phase ofrecovery, and the experience and skills of individual nurses, compounded further bychanges of nurses in different shifts. Hence, all three methods were tried on the sameinfant by the same nurse in a single working shift, each infant serving as its owncontrol. Feeds were given at intervals of 3 h. The study was cleared by the hospitaladministration and the Diplomate of National Board for Postgraduate Studies under

N. Malhotra et al. / Early Human Development 54 (1999) 29 –38 31

Fig. 1. The traditional infant feeding device, known as ‘paladai’ in some South Indian communities.

whom the first author was registered. Permission was taken from the mothers for theuse of these devices. The infant’s arms were restrained by wrapping the baby in asheet in order to prevent the hands from displacing the feeding utensil. In the case ofthe cup and paladai, milk was gently poured into the infant’s mouth, small amounts ata time. In the initial stages when the oral feed was tried for the first time, especially inthe small preterm and growth-retarded infants, distilled water was utilized for safetyreasons. Evaluation for the study was undertaken only when the infant could take theminimum volume of milk calculated for the weight and age by all three methods. Theparameters evaluated included the volume of milk ingested, the time taken for a feed,the degree of spilling, and the satiety relevant to the baby.

As the paladai was not graduated, the exact volume consumed could not be madeout directly. For this purpose sterilized graduated containers were used to collect andkeep the milk during feed times and to determine the volume of milk left after a feed.Separate containers were in any case required with larger babies, as the paladai usedin the unit had a capacity of only 30 ml.

2.1. Volume of milk ingested

As this too varied with the above-mentioned factors, it was expressed as ml /kg forpurposes of comparison.

32 N. Malhotra et al. / Early Human Development 54 (1999) 29 –38

2.2. Time taken for a feed

The time taken by the infant to consume the milk was noted as the volume ingestedover a fixed period (namely, ml /min) as total time taken was obviously influenced bythe total volume ingested and this in turn was influenced by the factors noted above.

2.3. The degree of spilling

A pre-weighed bib made of cotton with a non-permeable backing of plastic wasplaced under the baby’s chin during each feed. It was weighed again at the end of thefeed and the difference expressed as a percentage of the total amount of milk given.

2.4. Satiety

This was of course difficult to assess objectively and hence the number of hours thebaby kept quiet after each feed was noted.

2.5. Statistical evaluation

The mean and standard deviation values of the four variables (viz. the volumeconsumed, the time taken, the degree of spilling, and the satiety) were computed forthe three methods of feeding in all the infants; in group (I) (mature infants 2500 g ormore), group (II) (mature / term infants below 2500 g) and, group (III) (preterminfants below 37 weeks of gestation).

In all the infants and in group (I) the statistical significance of the differences inthe variables between the three methods were tested by applying parametric two-wayanalysis of variance. In case of significance, the significant pairs were identified byapplying multiple comparison test.

In groups (II) and (III), the significance of the differences in the values of thevariables between the three methods was tested by applying Friedman’s two-wayanalysis of the variance (non-parametric), since the sample sizes were comparativelysmall.

3. Results

The data are shown for all babies (Table 1), term infants 2500 g and above (Table2), mature infants below 2500 g (Table 3), and in the preterm babies (Table 4).

3.1. Volume of milk taken

In all groups, babies ingested more with the cup and most with the paladai. Thedifferences between the bottle and cup and the bottle and paladai were statisticallysignificant in all the groups. Some of the low-birthweight and preterm infants actuallyingested more than the ordered amount with the cup and paladai, especially the latter.The differences between the cup and paladai were significant when all the infants

N. Malhotra et al. / Early Human Development 54 (1999) 29 –38 33

Table 1Alternate methods of feeding all babies (n 5 100)

Parameter Bottle (A) Cup (B) Paladai (C) Statistical evaluation

A vs B A vs C B vs C

ml/kg 11.662.8 13.163.1 14.063.0 *** *** **ml/min 3.361.3 6.161.7 13.063.4 ** *** ***Spilling (%) 1.562.0 25.967.7 6.061.8 *** *** ***Satiety (h) 2.260.5 2.460.3 2.660.4 ** ** *

Mean P.O.G. (weeks), 38.062.2 (min., 30; max., 40.0); mean birth weight (g), 2789.16662.4 (min., 1240;max., 4700); mean age of starting (days), 2.566.84 (min., 1; max., 51).*P , 0.05; **P , 0.01; ***P , 0.001.

Table 2Alternate methods of feeding (group I, term weight, 2.5 kg or more (n 5 66))

Parameter Bottle (A) Cup (B) Paladai (C) Statistical evaluation

A vs B A vs C B vs C

ml/kg 11.062.0 12.061.4 12.761.7 ** ** **ml/min 3.761.2 6.661.5 13.863.3 ** *** ***Spilling (%) 1.361.9 22.965.5 5.561.6 *** *** ***Satiety (h) 2.360.4 2.560.4 2.660.4 ** ** *

Mean P.O.G. (weeks) 38.860.870 (min., 38.0; max., 40.0); mean birth weight (g) 3165.860.425 (min.,2555.0; max., 4700); all babies received feeds on day 1.*P , 0.05; **P , 0.01; ***P , 0.001.

Table 3Alternate methods of feeding (group II, term, weight , 2.5 kg (n 5 20)

Parameter Bottle (A) Cup (B) Paladai (C) Statistical evaluation

A vs B A vs C B vs C

ml/kg 13.162.0 14.862.2 15.162.1 ** ** bml /min 2.660.5 5.261.2 10.762.4 ** *** **Spilling (%) 1.962.3 28.565.7 6.061.6 *** ** ***Satiety (h) 2.260.3 2.460.2 2.660.2 * * b

Mean P.O.G. (weeks) 38.460.8 (min., 37.0; max., 40.0); mean birth weight (g) 22446155 (min., 1850;max., 2480); mean age (days) 1.461.0 (min., 1.0; max., 5.0). b, borderline significance.*P , 0.05; **P , 0.01; ***P , 0.001.

Table 4Alternate methods of feeding (group IV, preterm infants (n 5 14)

Parameter Bottle (A) Cup (B) Paladai (C) Statistical evaluation

A vs B A vs C B vs C

ml/kg 12.565.4 16.365.9 18.463.7 * ** bml /min 1.960.9 4.862.1 12.863.6 * *** **Spilling (%) 1.762.1 36.468.9 8.161.6 *** *** ***Satiety (h) 1.760.8 2.260.3 2.460.7 b * b

Mean gestation (weeks) 33.362.2 (min., 30; max., 36); mean birthweight (g) 1792.16391.3 (min., 1240;max., 2400); age of evaluation (days) 11.1616.2; (min., 1; max., 51). b, borderline significance.*P , 0.05; **P , 0.01; ***P , 0.001.

34 N. Malhotra et al. / Early Human Development 54 (1999) 29 –38

were considered (Table 1) and in normal weight infants (Table 2), but were only ofborderline significance in term growth-retarded babies (Table 3) and in preterminfants (Table 4), possibly because of the smaller numbers in the two latter groups.

Interestingly, four babies (two with birth asphyxia and two preterm), offered milkwhen they were felt to be ready for feeds as judged by their activity and suckingbehavior, were initially unable to suck adequately from the bottle but were able toaccept feeds with the paladai or cup, more readily with the former.

3.2. Time taken for a feed

Perhaps one of the striking features noted was the rapidity with which babiesingested milk with the paladai as compared with the bottle and the cup, especially theformer. There were no cases of choking or aspiration with this method during thestudy or subsequently so far in the unit. There was also no undue occurrence ofpossetting or vomiting beyond what was occasionally seen in the unit prior to theinitiation of this method. The other interesting point was the very relaxed manner inwhich the infants accepted the feeds. The exertion appeared to be far less than withthe bottle and cup. The nurses too appeared very comfortable with the use of thepaladai and all of them uniformly preferred this method over the other two.

3.3. The degree of spilling

As expected the spilling was greatest with the cup and least with the bottle, thedifferences being highly significant in all the groups. With the paladai, spilling wassomewhat more than with the bottle but far less than with the cup.

3.4. Satiety

Satiety as judged by the numbers of hours the infants kept quiet after a feed wasmore with the paladai and cup, especially the former, in the analysis of all the infantsand in group (I) with the normal term infants (Tables 1 and 2). This finding waspossibly related to increased intake with these two methods, especially with thepaladai. In mature low-birthweight infants (Table 3) and in preterm infants (Table 4),the differences were less marked and were significant primarily between the bottleand paladai, again perhaps due to smaller numbers.

3.5. Nurses’ views

The nurses were individually questioned about their opinions regarding the threemethods of oral feeding. They were unanimous in selecting the paladai as the methodof choice. The advantages highlighted included ease of cleaning and sterilization andof training the mothers, especially when compared to the bottle, and less timeinvolved in feeding. They also observed that there was far less effort or exertionrequired on the part of the infants. When asked to identify disadvantages, they all saidthat they could not identify any. On being asked to carefully reconsider, one nurse

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said that since the edges were sharp there could be a risk of injury to the lips,although they themselves did not note this complication.

4. Discussion

Conventionally, in the neonatal high risk unit, low-birthweight babies mostlygraduate from gavage feeds to the bottle and finally the breast although some centresnow try breastfeeding, at least once, before the bottle. In recent years, with thetendency to avoid the bottle, it is relevant to determine whether these infants canaccept other methods of oral feeding in this transition period before breastfeeding isfully established. The entity of ‘nipple confusion’ is yet to be proved in controlled,randomized studies [12]. However, it seems worthwhile to evaluate alternate methodsof feeding which may possibly avoid this potential problem and interfere less withbreastfeeding.

Interestingly, the volume of feeds ingested were more with the paladai and cup,especially the former. Surprisingly, the four babies who could not suck from thebottle, could accept feeds with the other two methods. This suggests that adequatesucking is not always necessary for swallowing as is conventionally implied. In fact,it supports an early study that showed that swallowing actually precedes thedevelopment of sucking [13].

The other unexpected finding was the rapidity with which the infants acceptedfeeds with the paladai. In fact, there was always a tendency when observing howquickly milk from a paladai disappeared into the infant’s mouth to tell the nurse toslow down. However, the babies were always noted to take the feeds in a comfortablerelaxed manner. As noted above, this study was only monitoring what the nurses werealready doing without initiating changes. It would appear from this evaluation,however, that feeds should probably be offered more slowly with the paladai. Further,when mothers are trained to use it in the community, they should be counselled not to‘force-feed’ the infant or feed during bouts of crying. We have had on occasions inthe community, aspiration of milk during bottle feeds given by mothers, sometimesdue to inappropriate size of the hole in the nipple. Hair pins, knives and scissors havebeen used to make these holes.

It must be noted that with use of the paladai and the cup, the nurse or motheradministering the feed has to constantly keep observing the infant during the feed. Incontrast, one has frequently observed that, during a bottle feed, the person mayactually be looking at other things and not necessarily be observing the infantthroughout the time of feeding. The former is actually an advantage because bettermonitoring and closer ‘social’ contact between the baby and caretaker are possible.As the feeding is not so time consuming this is more acceptable to busy nurses andmothers. Certainly, the question of propping it up like a bottle on a pillow next to thebaby does not arise at all.

We did not note the problem of cuts on the lip noted in another study [14]. Further,in contrast to what was studied in the latter, namely, gavage versus ‘paladai’, it wouldbe better to consider earlier initiation of oral feeds with the paladai in an infant on

36 N. Malhotra et al. / Early Human Development 54 (1999) 29 –38

gavage feeds rather than having a gavage or paladai situation right from thebeginning. In our unit we have observed that infants can graduate from gavage feedsto such oral methods far quicker than conventionally considered. Again, after initialfeeding of fixed, calculated volumes of milk, when infants with no medicalcontraindications are offered as much as they want we are now noting that theyinvariably accept volumes in excess of what is ordered.

Changes in interventions and policies may face resistance in many units, especiallyfrom the more experienced and well-established staff members who get used to setways. The paladai, however, was so readily accepted by the doctors and nurses thatthey have now actually given up the bottle in this neonatal unit. Its use now in over1000 babies who have received at least one feed with it has not been associated withcomplications. This is in spite of the fact that milk is actually poured into the baby’smouth and has been given by all the nurses and many mothers whose experience andskills have been variable.

Permitting infants to lap or sip from the cup has the distinct advantage of keepingthe feeding technique under the babies’ control. However, besides being excessivelytime consuming in some cases, there is a possibility that the intake may beinadequate, especially in the early stages. Efficiency will obviously improve withincreasing maturity and postnatal age, but it is also possible that many such babiesmay then actually be ready to accept direct breastfeeding.

Lack of sucking experience did not make the babies restless after the paladai andcup feeds. In fact, they were quieter for somewhat longer periods in most groups thanwith a bottle, possibly due to the larger volumes ingested.

We have found that small preterm babies can be given sucking experience evenduring phases of gavage feeding by use of non-nutritive sucking on the ‘emptied’breast just before the gavage feeds [6]. As an alternative, once a baby can acceptpaladai feeds, it has also been found to be very useful in the unit for supplementingbreastfeeds in low birthweight infants who are able to suck to some extent on thebreast but not adequate for intake of the full required nutrition. Since the effort andexertion in accepting the paladai was less than with the bottle, infants could morecomfortably accept expressed human milk even after sucking for some time on thebreast. Hence, this is useful in the transition period before the infant is ready forexclusive breastfeeding. It is easy to clean and sterilize and also more economicalthan the use of a bottle. The method can be taught to the mothers very easily.Low-birthweight infants can thus be discharged earlier, even before they are onexclusive breastfeeding. Decreasing hospital stay and cost of management wouldhave beneficial implications on a global basis.

Based on our personal experience we are instituting the following modifications.(1) Paladais can be made from stainless steel and good quality plastic or a suitable

alternative. The former can be sterilized by boiling and the latter, if similar to thequality of unbreakable feeding bottles, by boiling or by cold sterilization with, say,sodium hypochlorite. The edges should be smooth and rounded to avoid inadvertentinjury to the lips or gum margins. In advanced industrialized centres it can also be adisposable item.

(2) From preliminary evaluation it would appear that the capacity should be 25 or

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30 ml. It is also useful to have a small utensil with graduations to use as a measuringglass to know the volume of milk and for mixing powdered formula. Otherwise,many tend to use the feeding bottle for this purpose. Where this is done by nurses inhospitals, mothers may get a wrong notion that the bottle is actually being used forfeeding.

(3) We also need to study if it would be beneficial to have the paladai itselfgraduated by suitable marks, at least at intervals of 10 ml and, preferably, 5 ml. Thetype of marking should be evaluated to make sure that it permits easy cleaning andthat it does not promote harboring of germs.

Cups and paladais are already being used in various units. However, additionalcontrolled studies will provide more extensive and objective documentation of bothshort- and long-term features. Appropriate training will demonstrate how easily it canbe done and enhance skills in this area. Training of staff in hospitals and privatenursing homes, especially in developing countries is required, as many find it all tooeasy to offer a bottle. Promotion of breastfeeding requires not only positiveencouragement and appropriate lactation management but also an active effort todecrease or avoid the bottle, even in high-risk infants where breastfeeding is the finalgoal or has been opted for by the mother.

Acknowledgements

The authors are grateful to the Medical Superintendent, Moolchand Hospital forgranting permission to publish this paper and to the nursing and medical staffincluding the consultants, residents and nurses in the Department of Pediatrics andNeonatology, and Mr R.K. Ahuja, Research Officer, Department of Biostatistics, AllIndia Institute of Medical Sciences, for their kind cooperation.

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