Influence of Pacifiers on Breastfeeding Duration

Sudden Infant Death Clinical Trial

Official title:

Influence of Pacifiers on Breastfeeding Duration: a Multicentre, Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00306956
• Other study ID #: FUNDASAMIN101
• Status: Completed
• Phase: Phase 3
• First received: March 23, 2006
• Last updated: September 18, 2008
• Start date: March 2006
• Est. completion date: May 2008

Study information

• Verified date: September 2008
• Source: Fundacion para la Salud Materno Infantil
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1021
• Est. completion date: May 2008
• Est. primary completion date: August 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 18 Days

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Sudden Infant Death

Intervention

Behavioral:
• offer a pacifier
To offer a pacifier to normal newborn infants at 15 days of age

Locations

Country	Name	City	State
Argentina	Hospital Privado del Sur	Bahia Blanca	Buenos Aires
Argentina	Hospital Italiano de Buenos Aires	Buenos Aires
Argentina	Sanatorio de la Trinidad	Buenos Aires
Argentina	Hospital Diego Paroissien	Isidro Casanova	Buenos Aires
Argentina	Hospital Municipal Materno Infantil de San Isidro "Dr. Carlos Gianantonio"	San Isidro	Buenos Aires

Sponsors (2)

Lead Sponsor	Collaborator
Fundacion para la Salud Materno Infantil	International Childrens Medical Research Association, Switzerland.

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Three months	No
Secondary	To evaluate the effects of the pacifier's introduction when breastfeeding is firmly established at 15 days on the duration of breastfeeding		one year	No
Secondary	To evaluate the median breastfeeding duration in months in relation to the frequency of pacifier use		one year	No
Secondary	To test whether pacifier use is causally related with muguet, otitis and sore nipples		one year	No
Secondary	Compliance with group assignment		one year	No