The role and effect of limited formula use on breastfeeding and its discontinuation
| ISRCTN | ISRCTN61915183 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61915183 |
- Submission date
- 26/08/2015
- Registration date
- 07/09/2015
- Last edited
- 10/10/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English Summary
Background and study aims
It has long been thought that breastfeeding is the best way to feed new babies, as it provides hormones and disease-fighting substances that protect babies from illness. Producing enough milk for a new baby puts a great deal of strain on the mother’s body and, often, new mothers are often unable to produce enough milk to meet all of their baby’s needs during the first few months after birth. Breast milk is therefore sometimes accompanied with small amounts of formula, in order to make sure that babies are gaining enough weight. The pros and cons of supplementing breast milk with formula are widely debated, as some experts believe that bottle-feeding too early can lead to babies refusing to breastfeed. This study aims to find out whether giving babies very small amounts of formula at the same time as breast feeding will have an effect on the amount of babies who are being breastfed in the short and long term.
Who can participate?
Healthy babies with a normal birth weight, whose mothers are planning on breast feeding for a long time.
What does the study involve?
Mother and infant pairs are randomly allocated into two groups. The babies in the first group (intervention group) are given a set volume of 10ml of formula after each breastfeed until the mother is able to produce enough milk. The babies in the second group (control group) are exclusively breastfed, and receive no additional formula, unless the baby has lost more than 10% of its body weight since birth, is irritable, or if the mother specifically requests that the baby receive extra formula. Information about the babies’ feeding habits, as well as any weight changes are recorded by a nurse at 3 and 6 months after birth.
What are the possible benefits and risks of participating?
Comparing the two groups will help to find out if giving controlled amounts of formula may help support mothers and their babies in establishing breastfeeding and keeping the rates of breastfeeding up in longer term (3 months and 6 months). There are no known risks to participating as the comparison is with a standard approach to breastfeeding and formula feeding during hospitalisation after birth.
Where is the study run from?
Institute for the Care of Mother and Child (Czech Republic)
When is the study starting and how long is it expected to run for?
December 2013 to June 2015
Who is funding the study?
The Charles University Research Development Schemes (Czech Republic)
Who is the main contact?
Professor Zbynek Stranak
Contact information
Scientific
Podolske nabrezi 157
Prague
147 00
Czech Republic
 ORCID ID |
0000-0001-7095-3198 |
|---|
Study information
| Study design | Single-centre randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | 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 |
| Study hypothesis | We hypothesize that early limited formula feeds in infants with early weight loss will not adversely affect the rate of breastfeeding in the short and long term. |
| Ethics approval(s) | Institute for the Care of Mother and Child, 19/12/2013, ref: 2013-12-19-3 |
| Condition | Breastfeeding |
| Intervention | 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 exclusively breastfed. In the SA group supplemental feeds are administered only in indicated cases (excessive weight loss of more than 10%, irritability of the newborn and on the mother's specific request). Duration of intervention: formula administration from enrolment (see inclusion criteria) until the onset of lactation. Follow-up for all treatment arms is the same: at point of discharge, at 3 months and at 6 months of the infant's age |
| Intervention type | Other |
| Primary outcome measure | Breastfeeding rate at 3 month of age (value: Yes or No or to some extent) |
| Secondary outcome measures | 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) |
| Overall study start date | 01/12/2013 |
| Overall study end date | 01/06/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Lower age limit | 1 Day |
| Upper age limit | 2 Days |
| Sex | Both |
| Target number of participants | 100 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 01/01/2014 |
| Recruitment end date | 01/12/2014 |
Locations
Countries of recruitment
- Czech Republic
Study participating centre
Prague
147 00
Czech Republic
Sponsor information
Hospital/treatment centre
Podolske nabrezi 157
Prague
147 00
Czech Republic
"ROR" |
https://ror.org/03zd7qx32 |
|---|
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 31/10/2015 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| Publication and dissemination plan | We plan to submit the manuscript to international journals. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 26/02/2016 | Yes | No | |
| Dataset | 26/02/2016 | 10/10/2023 | No | No | |
| Protocol (other) | 26/02/2016 | 10/10/2023 | No | No |
Editorial Notes
10/10/2023: Protocol and dataset added.
29/02/2016: Publication reference added.
