Telephone Support From Primary Care for Breastfeeding Mothers

Status Recruiting

Clinical Trial Summary

The investigators will conduct a telephone-based support to breastfeeding women with healthy newborns to improve breastfeeding outcomes.

Clinical Trial Description

The World Health Organization recommends exclusive breastfeeding to infants until 6 months of age in order to achieve optimum growth. The proportion of exclusive breastfeeding mothers at 6 months is only 24.7 in Spain. The investigators believe it is important to increase the proportion of breastfeeding mothers in their population. Therefore, the investigators have developed a telephonic support protocol for mothers. The intervention will be performed by pediatric nurses in Primary Care.

The main aim of this study is to evaluate in a randomized controlled trial the effectiveness of telephone-based breastfeeding support in exclusive breastfeeding. The secondary aim is to evaluate the effectiveness of the telephonic support in any breastfeeding.

The investigators hypothesis is that this intervention will increase exclusive breastfeeding and any breastfeeding rates.

The study will be carried out in Cornellà, a semi-urban area near Barcelona. Participants will include breastfeeding women who have full-term healthy infants. Mothers will be recruited upon their first arrival to Primary Care from hospital. Eligible mothers who consent to participate will be randomized into either the intervention group or the control group. The latter will receive standard postpartum care. The former will receive standard postpartum care, plus a weekly telephone call during the first two months and every 2 weeks thereafter between the second and the sixth month. The pediatric nurse responsible for monitoring the standard care of each and every patient will be the one responsible for contacting them via telephone. Therefore, the study is not blinded.

The evolution of exclusive breastfeeding will be compared to artificial or supplemented feeding at 1, 2, 4 and 6 months. The effect of the intervention on breastfeeding supplemented with formula will also be valued. Classification into breastfeeding categories is based on 24-hour dietary recall. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Breast Feeding

Clinical Trial Details

NCT number	NCT02186613
Study type	Interventional
Source	Jordi Gol i Gurina Foundation
Contact	Josep Balaguer Martinez, Doctor
Phone	34-93-4712000
Email	jbalaguer@ambitcp.catsalut.net
Status	Recruiting
Phase	N/A
Start date	October 2014
Completion date	March 2016

View Details

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT04487418` - Evaluation of the Effects of High-level Laser and Electro-cautery in Lingual Frenotomy Surgeries in Infants	N/A
Completed	`NCT03334266` - Preventing Early Childhood Obesity, Part 2: Family Spirit Nurture, Prenatal - 18 Months	N/A
Enrolling by invitation	`NCT02687685` - Clinical Trial of Immediate Skin to Skin Contact at Birth Early vs. Immediate (CPPITLH)	N/A
Completed	`NCT02913638` - A Post Breastfeeding Follow-Up Study	N/A
Completed	`NCT03033459` - Prenatal Lactation-Focused Motivational Interviewing	N/A
Completed	`NCT02952950` - Is it Possible to Prolong the Duration of Breastfeeding in Premature Infants? a Prospectivt Study	N/A
Not yet recruiting	`NCT05846828` - Cognitive Functions in Breastfed Preschool Children
Completed	`NCT05629403` - Exclusive Breastfeeding Improves Puerperal Glucose Metabolism in Pregnant Women With Gestational Diabetes Mellitus and Links to Lipids Composition
Completed	`NCT05944471` - The Effect of Telehealth on Feeding Exclusive Breastfeeding in the Perception of Insufficient Milk	N/A
Completed	`NCT04024865` - Domperidone and Risk of Serious Cardiac Events in Postpartum Women
Recruiting	`NCT05560750` - Lingual Frenulum in Newborn Infants (LINNE)	N/A
Completed	`NCT03232762` - Effects of Diet on Pregnancy Outcome and Child Obesity	N/A
Completed	`NCT01687634` - Home Visiting for Low Income, Pregnant Women	N/A
Completed	`NCT01459991` - The Mediterranean Diet and Lactation Study: A Diet Study in Lactating Women	N/A
Completed	`NCT03574766` - Meditation for NICU Moms	N/A
Recruiting	`NCT03945474` - Osteopathic Manipulation in Breastfed Newborns	N/A
Recruiting	`NCT06107933` - Developmental Impacts of Microplastics Exposure in Early Life
Not yet recruiting	`NCT05059574` - Breast Crawling,Breastfeeding Success and Mothers' Attitudes to Feeding Their Babies	N/A
Completed	`NCT04578925` - Happy, Healthy, Loved: A Mobile-delivered Breastfeeding Self-efficacy Intervention for First Time Parents	N/A
Enrolling by invitation	`NCT03337893` - Investigation of Breastfeeding Protection Against Infant Infections and Childhood Diseases	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.