Clinical trial NCT00306956: Influence of Pacifiers on Breastfeeding Duration
Official title: Influence of Pacifiers on Breastfeeding Duration: a Multicentre, Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sudden Infant Death
Keywords: Infant
Newborn
pacifier
dummies
breastfeeding
Sudden Infant Death
SIDS
Pacifiers
Lead sponsor: Fundacion para la Salud Materno Infantil
Sponsor class: OTHER
Collaborators: name: International Childrens Medical Research Association, Switzerland.
First posted: 2006-03-27
Enrollment: 1021
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to determine if the introduction of pacifier use to infants at 2 weeks of age, once breast feedings are well established, will affect the incidence and duration of successful breastfeedings.

Detailed description: The incidence of Sudden infant death syndrome in developing countries is comparable with that of developed countries. Two important risk factors with implications for prevention are prone sleeping position and the association with smoke. Also, breastfeeding has been reported to be protective against SIDS.

In accordance with WHO/UNICEF recommendations, lactation consultants and other health professionals within "Baby-Friendly" institutions typically discourage the use of pacifiers in breastfed infants. The recent American Academy of Pediatrics policy statement, however, recommends pacifier use, during periods of sleep as a potential method to reduce the risk of SIDS. Previous observational studies had been unanimous in reporting an approximate doubling of the risk of early weaning with daily pacifier use. However, randomized controlled trials in developed countries, have not shown that giving pacifiers results in shorter breastfeeding duration, except when pacifiers are given in the first 5 days. It has therefore been seen that practically every author of a major study on the association between breastfeeding and pacifier use has proposed that the question can only be fully and completely answered by randomized studies. To date there are no large randomized studies evaluating the influence of pacifier use on breastfeeding duration.

Our Primary outcome is to compare the prevalence of exclusive breastfeeding at three months in infants between groups randomised to pacifier and no pacifier exposure once breastfeedings have been fully established.

Second outcome: to evaluate the effects of the pacifier's introduction when breastfeeding is firmly established at 15 days on the duration of breastfeeding.

Recruitment to the trial will take place in several public and private hospitals.

Those mothers who do not show a strong preference in regards to the introduction of the pacifier, will be randomised during the postpartum visit at 2 weeks (if well established breastfeeding is present) on two arms:

1. No pacifier,
2. Pacifier introduced at 15 days.

Structured telephone interviews will be conducted at 1, 2, 3, 4, 5, and 6 months and every 60 days thereafter until the breastfeeding has ended to record breastfeeding duration and type (exclusive or not) and pacifier use.

Eligibility criteria: Inclusion Criteria:

The following patients will be invited to participate before hospital discharge:

* Women who agree not to introduce the pacifier before 2 weeks
* Intention to exclusively breastfeed their infants for at least 3 months
* Breastfeeding exclusively at discharge
* Delivered a healthy singleton newborn
* 37 completed weeks and at least a 2.5 kg birth weight
* Possibility of contact by telephone
* Patients will be randomized at age 15 days if:

  * They are exclusively breastfeeding
  * They have no existing breastfeeding problems
  * Babies use no pacifiers.
  * Breastfeeding is well established
  * No maternal risk factors for lactation problems

Exclusion Criteria:

* Extremely or persistently sore nipples
* Presence of mastitis or abscess formation.
* Medical situations contraindicating breastfeeding

Primary outcomes:
measure: The prevalence of exclusive breastfeeding for three month old infants between groups randomised to pacifier and no pacifier exposure. Pacifier introduction is delayed until 15 days to ensure that breastfeeding is firmly established.
timeFrame: Three months
Secondary outcomes:
measure: To evaluate the effects of the pacifier's introduction when breastfeeding is firmly established at 15 days on the duration of breastfeeding
timeFrame: one year
measure: To evaluate the median breastfeeding duration in months in relation to the frequency of pacifier use
timeFrame: one year
measure: To test whether pacifier use is causally related with muguet, otitis and sore nipples
timeFrame: one year
measure: Compliance with group assignment
timeFrame: one year
Other outcomes:
Locations:
city: Bahia Blanca
country: Argentina
facility: Hospital Privado del Sur
state: Buenos Aires
city: Isidro Casanova
country: Argentina
facility: Hospital Diego Paroissien
state: Buenos Aires
city: San Isidro
country: Argentina
facility: Hospital Municipal Materno Infantil de San Isidro "Dr. Carlos Gianantonio"
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
city: Buenos Aires
country: Argentina
facility: Sanatorio de la Trinidad
Study officials:
affiliation: Jefe de Recién Nacido Normal, Hospital Italiano, Buenos Aires
name: Alejandro Jenik, M.D.
role: PRINCIPAL_INVESTIGATOR
References: