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The role and effect of limited formula use on breastfeeding and its discontinuation

A prospective, randomized trial comparing the use of controlled limited formula (CLF) to a standard approach (SA) for efficiency and duration of breastfeeding in neonates

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN61915183
Enrollment
100
Registered
2015-09-07
Start date
2014-01-01
Completion date
Unknown
Last updated
2023-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breastfeeding Not Applicable

Interventions

Infants in the CLF group (intervention group) are given a set volume of 10 ml of formula after each breastfeed until adequate milk production begins. Infants in the SA group (control group) are exclus

Sponsors

Institute for the Care of Mother and Child
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Healthy term neonates with weight loss =5 per cent between 24th and 48th hour of life 2. Singleton 3. Eutrophic with birth weight between 2500 – 4000 grams 4. Born after uncomplicated pregnancy and delivery 5. No severe congenital defects 6. Mothers are planning to breastfeed for a long time

Exclusion criteria

Exclusion criteria: 1. Mother-infant pairs with serious maternal complications (hypertension, diabetes, systemic diseases, drug abuse) 2. Mothers using therapy that might affect breastfeeding, e.g. antidepressants

Design outcomes

Primary

MeasureTime frame
Breastfeeding rate at 3 month of age (value: Yes or No or to some extent)

Secondary

MeasureTime frame
1. Exclusive breastfeeding at 3 months of age (value: Yes or Not) 2. Breastfeeding at 6 months of age (value: Yes or No or to some extent) 3. Exclusive breastfeeding at 6 months of age (value: Yes or Not) 4. Weight loss - the loss of weight during birth hospitalization (calculated as actual weight/birth weight x 100) 5. Weight loss - the loss of weight during birth hospitalization (calculated as actual weight/birth weight x 100)

Countries

Czech Republic

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 2, 2026