Early Limited Formula for Treating Lactation Concerns

Breastfeeding Clinical Trial

— ELF-TLC  

Official title:

Early Limited Formula for Treating Lactation Concerns

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02313181
• Other study ID #: R40-MC26810
• Status: Completed
• Phase: N/A
• Start date: January 7, 2015
• Est. completion date: October 1, 2017

Study information

• Verified date: May 2018
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized, controlled trial designed to evaluate a new strategy for promoting continued breastfeeding for mothers and babies who initiated breastfeeding in the newborn period. The new strategy, called Early Limited Formula (ELF), consists of 10mL of formula fed to each baby by syringe after each breastfeeding prior to the onset of mature milk production. The study intervention is discontinued at the onset of mature milk production, and the investigators will then follow mothers and infants for 12 months to assess the effect of ELF on breastfeeding duration, maternal experience and healthcare utilization.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 328
• Est. completion date: October 1, 2017
• Est. primary completion date: March 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 72 Hours

Eligibility

Inclusion Criteria:

1. Full term, healthy singleton infant (= 37 0/7 weeks gestational age) in well newborn nursery

2. Exclusively breastfeeding (has not received any feedings other than breast milk)

3. Infant is 18-72 hours old

4. Infant has weight loss of =75th percentile on delivery mode specific nomogram documented at 12-72 hours of age

5. English-speaking mother

Exclusion Criteria:

1. Mothers or infants for whom breastfeeding is not recommended by the clinical team

2. Mothers who have already begun to produce mature breast milk

3. Any formula or water feeding prior to enrollment

4. Infants who have already lost =10% of their birth weight

5. Family with no active telephone number (home or cellular)

6. Plan for infant adoption or foster care

7. Mothers <18 years of age

8. Infant receiving scoring for Narcotic Abstinence Syndrome -

Related Conditions & MeSH terms

• Breastfeeding

Intervention

Other:
• Early Limited Formula
10 milliliters (mL) Nutramigen fed to baby by syringe after each breastfeeding and discontinued at the start of mature milk production
• Standard Care
Continue exclusive breastfeeding unless otherwise directed by a health care provider

Locations

Country	Name	City	State
United States	Penn State Hershey Medical Center	Hershey	Pennsylvania
United States	University of California, San Francisco Medical Center	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Francisco	HRSA/Maternal and Child Health Bureau, Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Edinburg Postnatal Depression Scale	The investigators will follow mothers for 1 month to determine their score on the Edinburg Postnatal Depression Scale	1 month
Other	Breastfeeding Self-Efficacy Scale	The investigators will follow mothers for 1 month to determine their score on the Breastfeeding Self-Efficacy Scale	1 month
Other	Satisfaction with Quality of Care	The investigators will follow mothers for 1 month to determine their score on the Satisfaction with Health Care Following Childbirth Scale	1 month
Other	Milk supply concern	The investigators will follow mothers for 1 month to determine their score on the Infant Satisfaction and Satiety Subscale	1 month
Primary	Length of breastfeeding duration	The investigators will follow babies for 12 months to determine how long the babies continued breastfeeding	12 months
Secondary	State Trait Anxiety Inventory	The investigators will follow mothers for 1 month to measure their responses on the State Trait Anxiety Inventory.	1 month
Secondary	Health care utilization	The investigators will follow babies for 1 month to determine how often they were seen by an outpatient provider, inpatient provider or emergency provider.	1 month
Secondary	Formula use	The investigators will follow babies for 6 months to determine the volume of formula used.	6 months