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Clinical Research
Effects of Pacifier Use on Transition Time
from Gavage to Breastfeeding in Preterm Infants:
A Randomized Controlled Trial
AU1 cBirgul Say,
1
Gulsum Kadioglu Simsek,
2
Fuat Emre Canpolat,
2
and Serife Suna Oguz
2
Abstract
Background: Nonnutritive sucking (NNS) has been identified as having many benefits for preterm infants. NNS
may improve the efficacy of oral feeding, reduce the length of time spent in orogastric (OG) tube feeding, and
shorten the length of hospital stays for preterm infants.
Aim: This study aimed to assess the effect of pacifiers on preterm infants in the transition from gavage to oral
feeding, their time to discharge, weight gain, and time for transition to full breastfeeding.
Methods: A prospective, randomized controlled trial was conducted in our center. Ninety infants were ran-
domized into two groups: a pacifier group (PG) (n=45) and a control group (n=45). Eligibility criteria included
body weight less than or equal to 1,500 g, gestational age (GA) younger than 32 weeks, tolerating at least 100
kcals/kg/day by OG feeding, growth parameters appropriate for GA, and a stable clinical condition.
Results: Mean GAs were 29.2 –1.86 versus 28.4 –1.84 weeks ( p=0.46), and birth weights were 1,188.2 –272
versus 1,112.8 –267 g ( p=0.72) in the PG and CG groups, respectively. The time for transition to full oral
feeding (38 –19.2 days), time to transition to full breastfeeding (38.1 –20 days), and time to discharge
(48.4 –19.2 days) in the PG were significantly shorter compared with the control group (49.8 –23.6, 49.1 –22,
65.3 –30.6 days, respectively) ( p<0.05). For preterm infants with gastrointestinal motility disturbance, similar
symptoms (regurgitation, vomiting, abdominal distension) (n=6, 22%) in the PG were significantly lower than
the control group (n=21, 77.8%) ( p<0.05).
Conclusion: In this study, we determined that the method of giving pacifiers to preterm infants during gavage
feeding reduced the infants’ transition period to oral feeding and the duration of hospital stay. In addition, the
pacifiers could be used during gavage feeding and in the transition from gavage to oral/breastfeeding in preterm
infants to encourage the development of sucking ability.
AU2 cKeywords: pacifier, breastfeeding, preterm infants
Introduction
The survival of
AU3 cpreterm infants has significantly in-
creased over the last 20 years. Nevertheless, oral feeding
challenge is one of the most frequently encountered problems
in preterm infants. One of the main causes for a prolonged
length of stay in the hospital for preterm infants is the failure
to complete effective breastfeeding.
1
It is very important for
preterm infants to start oral feeding immediately.
2
Pacifier
use improves nonnutritive sucking (NNS) by oral stimula-
tion.
3
NNS is organized as a series of bursts of rapid sucks
followed by rest periods. Sucking behavior is principally
controlled by a neuronal network, the suck central pattern
generator. The development of this specialized neural circuit
can be delayed as a consequence of the prematurity of in-
fants.
4
Coordinated feeding in infants requires the sensorial
and motor integration of sucking, swallowing and breathing,
where several muscle groups participate in an observable
rhythmic process.
5
Although sucking movements exist from
the 28th gestational week, feeding must be started thorough
gavage methods (nasogastric/orogastric) for preterm infants.
Improvement of sucking in preterm infants may be achieved
gradually and spontaneously at 34 weeks of gestational
corrected age.
2,5
Some studies showed that by using vari-
ous external stimuli (pacifier, lullaby, music, breast milk
smell, kangaroo care, etc.), preterm infants can proceed to
1
Division of Neonatology, Derince Education and Training Hospital, Kocaeli, Turkey.
2
Division of Neonatology, Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey.
BREASTFEEDING MEDICINE
Volume XX, Number XX, 2018
ªMary Ann Liebert, Inc.
DOI: 10.1089/bfm.2018.0031
1
BFM-2018-0031-ver9-Say_1P
Type: clinical-research
BFM-2018-0031-ver9-Say_1P.3d 06/11/18 4:47pm Page 1
oral feeding earlier than the 34th gestational week.
2
Via
sensory-motor stimulation, pacifier use might also help in
achieving oral feeding and reducing hospital stay. At the
same time, NNS provided by a pacifier might elicit different
physiological, pharyngeal, and esophageal motility events,
potentially affecting gastroesophageal reflux.
6
In addition,
advantages of pacifier use for preterm infants have been
defined, which include neurodevelopmental organization,
supporting neurobehavioral maturation, and optimizing ven-
tilation in preterm infants who require nasal noninvasive
ventilatory support, as well as reducing pain.
7
The World
Health Organization (WHO) proscribes the use of a pacifier
in the list of 10 steps toward successful breastfeeding.
8
Many
studies have shown that pacifier usage during gavage feeding
may encourage the development of the sucking behavior of
preterm infants.
9
Therefore, the risks and benefits of pacifiers
need to be clarified.
The aim of this research was to assess the effect of giving
pacifiers to preterm infants on the transition period to oral
feeding, time at transition to full breastfeeding, time to dis-
charge, body weight at discharge, weight gain rate, and
gastrointestinal intolerance symptoms.
Methods
This prospective, single-center, randomized, controlled
study was conducted in the
AU4 cNICU of the University of Health
Sciences Zekai Tahir Burak Maternity Teaching Hospital
between July 2016 and November 2017. The trial was ap-
proved by the local Ethics Committee. Written informed
parental consent was obtained for each patient. Inclusion
criteria for enrollment in this study were that the preterm
infants had a gestational age (GA) between 26 and 32 weeks,
had a stable clinical condition and full enteral feeding with an
orogastric (OG) tube, and had a birthweight of 1,500 g or less.
A simple randomization method was used to allocate infants
to groups. The research was conducted with 90 preterm in-
fants. The infants were divided into two groups as follows:
(1) control group, including 45 infants not using pacifiers and
(2) pacifier group (PG), including 45 infants using pacifiers.
In the present study, the PG and the control group were
compared in terms of time to transition to full breastfeeding
and full oral feeding, time to discharge, and daily weight
gain of the preterm infants. Preterm infants with congenital
anomalies, perinatal asphyxia, prolonged respiratory distress,
intraventricular hemorrhage of greater than grade 2 accord-
ing to the Papille classification,
10
hyperbilirubinemia requiring
exchange transfusion, or intestinal anomalies or necrotizing
enterocolitis with a Bell stage ‡2
11
were excluded. In addition,
preterm infants receiving invasive or noninvasive mechanical
ventilator support were excluded from the study. For preterm
infants, an intravenous dextrose solution was begun after de-
livery. This was followed, usually within 24–36 hours, with
total parenteral nutrition and lipids. Trophic or low-volume
gavage feedings were started within the first days of life. In-
fants were gavage fed until they were developmentally and
physiologically ready to begin the process of learning to suck,
swallow, and breathe in a coordinated manner. Preterm infants
who did not need total parenteral nutrition were fed via an OG
tube and cared for in the neonatal intensive care. Feeding was
carried out every 2 or 3 hours via OG tube according to the
weight of the infants. The required amount of breast milk that
should be given to the preterm infant for energy need was
calculated by a neonatologist. A pacifier was used every day
during four feedings and the postprandial period. The attend-
ing nurse regularly checked that the pacifier was in place and
periodically slightly alerted it to stimulate the sucking reflex.
In the PG, before and after the feeding time for a total of four
times a day, preterm infants were allowed to use pacifiers for
15 minutes. The mothers use an electric pump (Ameda, Lin-
colnshire, IL) to empty her breast just before the infant’s ga-
vage feeding time. Preterm infants were fed with a syringe
during the transition to the mother’s breast. When the oral
feeding process was completed, pacifier implementation was
also terminated. In the control group, no procedure other than
standard nursing care was applied to the preterm infants in the
control group. Since our hospital is a Baby-Friendly Hospital,
there was no pacifier and no bottle use inroutine practice in the
NICU. The study flow diagram for the enrollment of the pre-
term infants is shown in bF1
Figure 1.
FIG. 1. bAU7
Flowchart.
2 SAY ET AL.
BFM-2018-0031-ver9-Say_1P.3d 06/11/18 4:47pm Page 2
The pacifier used in the present study was ‘‘From Read
McCarty, Inventor of GumDrop
!
& Soothie
!
, Hawaii Med-
ical GumDrop Pacifier, USA.’’ Time to full enteral feeding,
OG tube feeding time, time at transition to full breastfeeding,
time to discharge, weight at discharge, daily body weight, and
gastrointestinal intolerance symptoms of the preterm infants
were recorded during the study.
Statistical analysis
Data were analyzed using IBM SPSS Statistics 21.0
(SPSS, Inc., Chicago, IL) statistical package program, and
statistical significance was set at p<0.05. A descriptive anal-
ysis of the demographic and clinical characteristics of the
patients was conducted. Student’s t-test for parametric data
or Mann–Whitney Utest for nonparametric data was used
for comparison of variables between the two groups. Chi-
square test was used to compare ratios between the two groups.
Results
Participant flow and follow-up: we invited 100 women to
participate, 5 refused (Fig. 1). During the study, three cases
were excluded from the PG and two cases were excluded
from the control group due to unstable clinical state. Thus, 90
infants were enrolled and available for the primary analyses
(PG, n=45; control group, n=45). Characteristics of the
participants, including both maternal and neonatal charac-
teristics, were balanced between the groups (
T1 cTable 1). The
time to start pacifier use for preterm infants in the PG was a
mean of 29.64 days. Mean GAs were 29.2 –1.86 versus
28.4 –1.84 weeks ( p=0.46), and birth weights were 1,188.2 –
272 versus 1,112.8 –267 g ( p=0.72) in the PG and CG
groups, respectively. The comparison of control and PGs is
presented in
T2 cTable 2. There were no significant differences in
late neonatal sepsis, time to reach birth weight, body weight
at discharge, and body weight gain (g/day). However, there
were significant differences between the groups in gavage
feeding duration, time for transition to full breastfeeding
and time to discharge ( p<0.05). The time for transition to
full oral feeding (38 –19.2 days), time to transition to full
breastfeeding (38.1 –20 days), and time to discharge (48.4 –
19.2 days) in the PG were significantly shorter than the
control group (49.8 –23.6, 49.1 –22, 65.3 –30.6 days, re-
spectively) ( p<0.05). In addition, for preterm infants with
gastrointestinal motility disturbance, similar symptoms (re-
gurgitation, vomiting, abdominal distension) (n=6, 22%)
in the PG were significantly lower than the control group
(n=21, 77.8%) ( p<0.05).
Discussion
Studies on pacifier use have reported that its use in preterm
infants helps make the baby awake and active before feeding.
It also helps to increase the secretion of gastrointestinal
hormones by accelerating the development of the sucking
reflexes of the infant. In this study, pacifier use significantly
decreased the time of transition from gavage feeding to oral
feeding and duration of hospital stay. A meta-analysis by
Pinelli and Symington showed that positive outcomes were
demonstrated for NNS with respect to reduced length of
hospital stay.
12
Orocutaneous therapy using pacifiers has
been associated with nonnutritive suck development and en-
hanced feeding performance,
12
in addition to decreased length
of hospitalization.
Pacifiers are not recommended for term infants because of
the relationship between pacifier use and decreased incidence
of exclusive breastfeeding (EBF). NNS, however, has been
found to strengthen the preterm infant’s oral-facial muscu-
lature, lead to more effective bottle feeding, and significantly
decrease the length of hospitalization. Because of these
positive effects, preterm infants are traditionally provided
pacifiers to improve their oral motor skills at the earliest
possible GA.
13,14
Some studies also demonstrated a positive
effect of NNS on the exhibited less defensive behaviors
during tube feeding.
9,14
Some researchers found that pacifier
use has been identified as a factor associated with shorter
duration of EBF in observational studies.
15
However, preterm
infants with immature neurological development and unco-
ordinated sucking-swallowing-breathing pattern cannot be
fed by mouth successfully and safely.
15
Therefore, it is
important that improving sucking skills and pacifier use
Table 1. Comparison of Control and Pacifier Groups According to the Preterm
Infant’s and Mother’s Descriptive Characteristics
Variables Pacifier group (n=45) Control group (n=45) p
Maternal age, year
a
29.2 –5.5 27.4 –5.8 0.90
Gestational age, weeks
a
29.2 –1.86 28.4 –1.84 0.46
Birth weight, g
a
1,188.2 –272 1,112.8 –267 0.72
Caesarean delivery, n(%) 38 (48.7) 40 (51.3) 0.75
Male, n(%) 27 (60) 18 (40) 0.09
Antenatal steroids, n(%) 30 (51.7) 28 (48.3) 0.82
Premature rupture of membrane >18 hours, n(%) 7 (31.8) 15 (68.2) 0.08
Apgar score at 1 minutes, median (min-max) 6 (3–7) 6 (4–8) 0.25
Apgar score at 5 minutes, median (min-max) 8 (5–9) 8 (5–9) 0.16
Multiple pregnancies, n(%) 26 (34) 22 (29) 0.48
Small for gestational age, n(%) 7 (46.7) 8(53.3) 1
Maternal preeclampsia, n(%) 13 (17) 14 (18) 1
Chorioamnionitis, n(%) — 2 (2.7) 0.72
Patent Ductus Arteriosus, n(%) 16 (43.2) 21 (56.8) 0.39
Necrotizing Enterocolitis, stage ‡II, n(%) — —
a
Mean –SD.
EFFECTS OF PACIFIER USE IN PREMATURE INFANTS 3
BFM-2018-0031-ver9-Say_1P.3d 06/11/18 4:47pm Page 3
recommendations need to be based on a benefit-risk ap-
proach focus for preterm infants. A Cochrane review found
that nonnutritive sucking is associated with shorter hospi-
tal stays, earlier transition to bottle feeding from enteral
feeding, and improved bottle feeding. Although the review
did not show that pacifiers have a significant impact on
weight gain, behavior, energy intake, heart rate, oxygen satu-
ration, or age at full oral feeding, none of the studies reported
harmful effects from pacifier use.
16
Furthermore, oral feeding is a complex multisystem pro-
cess involving the integration of lips, jaw, cheeks, tongue,
palate, pharynx, and larynx.
15
Pacifiers are used as a means
for providing sensitivity to mechanical stimuli such as pres-
sure to the orofacial and lingual sucking apparatus for acti-
vating the sensory-motor components of cranial nerves V,
VII, IX, X, and XII that are involved in safe feeding.
12
The
pharyngoesophageal motility of preterm infants does mature
with increasing postnatal age. In this study, gastrointestinal
motility disturbance with similar symptoms (regurgitation,
vomiting, abdominal distension) in the PG was significantly
lower than the control group (22%, 77.8%, respectively)
(p<0.05). The Cochrane review by Pinelli and Symington
also included studies of the effect of NNS in preterm infants
on a number of outcomes related to gastrointestinal function
and feeding. The results of that review revealed no significant
effect of NNS on weight gain, energy intake, intestinal transit
time, postconceptional age at full oral feeding, and energy
expenditure.
16
Another systematic review by Premji and Paes
using many of the same studies came to similar conclusions,
that is, the effects of gastric emptying and weight gain on
preterm infants were inconclusive.
17
In our study, we ana-
lyzed the effects of pacifier use on the time at transition from
gavage feeding to oral feeding, time at transition to full
breastfeeding, time to discharge and duration of hospital
stay of gavage-fed premature infants. The time for transi-
tion to full oral feeding (38 –19.2 days), time to transition to
full breastfeeding (38.1 –20 days), and time to discharge
(48.4 –19.2 days) in the PG were significantly shorter com-
pared with the control group (49.8 –23.6, 49.1 –22, 65.3 –
30.6 days, respectively) ( p<0.05). However, there were no
significant differences in body weight at discharge or body
weight gain in our study ( p>0.05). One study of 71 infants
ranging from 26.7 to 35.9 weeks GA found that extremely
preterm infants allowed NNS at the breast were able to
latch on and demonstrate nutritive sucking as early as 30
weeks GA.
17
Medical and public health organizations recommend that
mothers exclusively breastfeed for at least 6 months.
18
NNS
at the breast has been associated with longer breast-feeding
duration and allows the critically ill infant to have a smooth
transition at breast feeds.
19
Nonnutritive sucking at the breast
should be initiated once an infant has been extubated.
20
However, the lack of a mother hotel in our hospital made it
difficult for mothers to access it at certain intervals during the
day. Because of this reason the mothers are unable to do NNS
with the infants at the breast. This is a limitation of the study.
Most of the 26,000 babies born each year or admitted to the
Zekai Tahir Burak Maternity Teaching Hospital are prema-
ture, as the hospital handles high-risk births. The high rate of
hospitalization in our neonatal intensive care units and the
low socioeconomic level of the mothers led us researchers to
do such studies. Although hospitalization costs of preterm
infants are covered by the state in our country, the difficulty
of educating a mother, the prolongation of the hospitalization
period of preterm infants, and the complications related to it
should also be considered. In addition to the WHO recom-
mendation, which is generally accepted around the world, it
is necessary for units to act according to their specific prob-
lems and the characteristics of their populations.
19
Disclosure Statement
No competing financial interests exist.
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LNS, day
a
12.8 –5.6 17.5 –17.2 0.28
LNS (clinically suspected), n(%) 15 (33) 18 (40) 0.37
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6 (22.2) 21 (77.8) 0.001
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a
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a
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Address correspondence to:
Birgul Say, MD
Division of Neonatology
Derince Education and Training Hospital
Karadenizliler Suburb.
_
Izmit
Kocaeli 41310
Turkey
E-mail: birgullivasay@gmail.com;
birgullivasay@yahoo.com
EFFECTS OF PACIFIER USE IN PREMATURE INFANTS 5
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