Condition category
Not Applicable
Date applied
26/08/2015
Date assigned
07/09/2015
Last edited
29/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Zbynek Stranak

ORCID ID

http://orcid.org/0000-0001-7095-3198

Contact details

Podolske nabrezi 157
Prague
147 00
Czech Republic

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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.

Acronym

Study hypothesis

We hypothesize, that early limited formula feeds in infants with early weight loss will not adversely affect the rate of breastfeeding in short-term and long-term.

Ethics approval

Institute for the Care of Mother and Child, 19/12/2013, ref: 2013-12-19-3

Study design

Single-centre randomized controlled trial.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Breastfeeding

Intervention

Infants in the CLF group (intervention group) are given a set volume of 10ml 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 more than 10%, irritability of the newborn and on mothers specific request).
Duration of intervention: formula administration from enrolment (see inclusion criteria) until onset of lactation.
Follow up for all treatment arms is the same: at point of discharge, at three months and at 6 months of infant's age

Intervention type

Phase

Drug names

Primary outcome measures

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 trial start date

01/12/2013

Overall trial end date

01/06/2015

Reason abandoned

Eligibility

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 type

Patient

Age group

Neonate

Gender

Both

Target number of participants

100

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

Trial participating centre

Institute for the Care of Mother and Child
Podolske nabrezi 157
Prague
147 00
Czech Republic

Sponsor information

Organisation

Institute for the Care of Mother and Child

Sponsor details

Podolske nabrezi 157
Prague
147 00
Czech Republic

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

University/education

Funder name

The Charles University Research Development Schemes (PRVOUK32)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We plan to submitt the manuscript to international journals.

Intention to publish date

31/10/2015

Participant level data

Stored in repository

Results - basic reporting

Publication summary

2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26918700

Publication citations

Additional files

Editorial Notes

29/02/2016: Publication reference added.