Status:
COMPLETED
Influence of Pacifiers on Breastfeeding Duration
Lead Sponsor:
Fundacion para la Salud Materno Infantil
Collaborating Sponsors:
International Childrens Medical Research Association, Switzerland.
Conditions:
Sudden Infant Death
Eligibility:
All Genders
14-18 years
Phase:
PHASE3
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 success...
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 pos...
Eligibility Criteria
Inclusion
- 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
- Extremely or persistently sore nipples
- Presence of mastitis or abscess formation.
- Medical situations contraindicating breastfeeding
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
1021 Patients enrolled
Trial Details
Trial ID
NCT00306956
Start Date
March 1 2006
End Date
May 1 2008
Last Update
September 19 2008
Active Locations (5)
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1
Hospital Privado del Sur
Bahía Blanca, Buenos Aires, Argentina, 8000
2
Hospital Diego Paroissien
Isidro Casanova, Buenos Aires, Argentina, 1765
3
Hospital Municipal Materno Infantil de San Isidro "Dr. Carlos Gianantonio"
San Isidro, Buenos Aires, Argentina
4
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina, 1181ACH