Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Hospital Italiano de Buenos Aires | OTHER |
| Fundacion para la Salud Materno Infantil | OTHER |
Not provided
Not provided
Not provided
Not provided
We will enroll 1010 mother-infant dyads in a randomized trial exploring the effect of distribution of the pacifier during the first days of life on breastfeeding prevalence and duration. .
Given the scarcity of scientifically rigorous studies that address the impact of unrestricted pacifier exposure on breastfeeding we plan to conduct a multicenter, randomized, single blind, active control, parallel assignment, efficacy study to assess the impact of offering a pacifier on breastfeeding during the first days of life our hypothesis is that the introduction of a pacifier during the first days of life does not interfere with lactation
A research assistant will approach all eligible mothers during the first 6 hours after birth and will invite them to be randomized to one of the two groups:
Unrestricted pacifier ( the pacifiers can be offered liberally to infants to suck on during their stay at the facility providing maternity and newborn services) and Restricted pacifier group: ( avoid pacifier use until breastfeeding is well established) Women will be followed up at 1, 3, 4, ,6, 8, and 12 months after birth or until breastfeeding ended by a research assistant blinded to the group assignment. Interviews will be conducted by telephone using structured questionnaires designed to assess breastfeeding (exclusive or partial) prevalence and duration, and whether or not the baby had rejected a pacifier the night before the telephone interview. Rates of exclusive, partial, and any other occasional random breastfeeding will be tracked at all these time points.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A: unrestricted pacifier | Experimental | recommendation to offer a pacifier at the facility providing maternity and newborn services the first days of life |
|
| restricted pacifierr | Active Comparator | recommendation not to offer a pacifier to normal new born infant at the maternity thre first days of live |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| offer a pacifier | Behavioral | offer a pacifier to normal newborn infants the first days of life |
|
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of exclusive breastfeeding | To compare the prevalence of exclusive breastfeeding at three, four and six months in infants between groups randomized to unrestricted pacifier group and restricted pacifier group | up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| infant feeding - breastfeeding duration | to evaluate the duration of exclusive and any breastfeeding duration in months between the two groups | up to 24 weeks |
Not provided
Inclusion Criteria
Exclusion Criteria:
Maternal risk factors for lactation
Psychosocial problems (eg, depression, poor or negative support of breastfeeding
Mother with a chronic condition that could influence development , including feeding ability
Mother with eating or mental disorder.
Mothers who smoke during pregnancy
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alejandro G Jenik | Contact | 5491144061380 | alejandro.jenik@hiba.org.ar |
| Name | Affiliation | Role |
|---|---|---|
| alejandro G Jenik, MD | Fundacion para el Estudio y la Prevencion de la Muerte Infantil y Perinatal | Principal Investigator |
| Aleajndro G Jenik, MD | Fundacion para erl Estudio y Prevencionde la Muerte Subita y Perinatal |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Privado de del Sur | BahÃa Blanca | Buenos Aires | 8000 | Argentina | ||
| Hospital Italiano de buenos Aires |
weight,gestational age,mother age, vaginal, cesarean,bedsharing, contact skin to skin
data will be available within 6 months of study
data access requests will be reviewed by an external independent review panel. Requestors will be required to sifn a Data Access Agreement
Not provided
| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| no pacifier | Behavioral | not to offer a pacifier at 15 days of life |
|
| CABA |
| Buenos Aires |
| 1199ABB |
| Argentina |
| Sanatorio de la Trinidad | CABA | Buenos Aires | 1425 | Argentina |
| Alejandro Jenik | Olivos | Buenos Aires | 1636 | Argentina |
|
| Hospital Municipal Materno Infantil de San Isidro "Dr. Carlos Gianantonio"t | San Isidro | Buenos Aires | Argentina |
| Centro Agustin Rocca HIBA | San Justo | Buenos Aires | B1702 | Argentina |