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Infant, Very Low Birth WeightPhase 4NCT00703950

Sucking Pattern of Preterm Infants Using Cup or Bottle Before Breastfeeding

A Phase 4 study testing cup feeding and bottle feeding in people with Infant, Very Low Birth Weight, run by Instituto Fernandes Figueira at 1 site in Brazil.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The aim of this study is evaluates the effect of the use of bottle and cup in breast sucking patterns in preterm infants. It will be a randomized blind study. One group will be randomized to use bottle to feed and another one to use a cup to feed. Read more about this study

Who is it for?
Ages 29 to 33 weeks
Conditions the study is for
Infant, Very Low Birth Weight
What is being tested?
cup feeding and bottle feeding
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteBrazil
Study dates
Jan 2008to Dec 2013
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 29 to 33 weeks
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • very low birthweight
  • gestational age from 26 to 32 complete weeks
  • absence of congenital anomalies in the face, head and neck
  • absence of severe asphyxia
  • negative serology for AIDS
  • mothers willing to breastfeed
  • absence of pulmonary disease

Who cannot join

  • severe intraventricular hemorrhage
  • necrotizing enterocolitis
  • infection after the beginning of the trial

Trial locations and contacts

1 site in 1 country.

Brazil1 site
  • Instituto Fernandes Figueira

    Rio de Janeiro, Rio de Janeiro, 22250020

Other trials in Brazil

About this study

Official title: Effects of the Use of a Bottle and a Cup on Breast Sucking Patterns of Premature Infants: Safety and Efficacy

The aim of this study is evaluates the effect of the use of bottle and cup in breast sucking patterns in preterm infants. It will be a randomized blind study. One group will be randomized to use bottle to feed and another one to use a cup to feed. As secondary endpoints, weight gain, days of life to begin full oral feeding, length of hospital stay and breast feeding rates will be observed.

Read the detailed description

Breastfeeding is the better method to promote adequate growth and development in preterm infants. However, sometimes preterm infants needs to be supplemented with the own mother milk or formula using another methods.

The cup and the bottle have been used in neonatal units, however there is still no evidence to determine the best feeding method, which must be safe, efficient and not jeopardize breast feeding.

The aim of this study is evaluates the effect of the use of bottle and cup in breast sucking patterns. The intervention will be the use of bottle or cup to feed preterm infants before or to supplement breastfeeding after randomization. Nowadays, bottle feeding is the conventional method and we wish to compare sucking patterns after use of bottle or cup. As secondary endpoints, weight gain, days of life to begin full oral feeding, length of hospital stay and breast feeding rates will be observed. In order to achieve this aim, a blind randomized clinical trial will be done with 96 very low birth weight infants, in which a group is randomly selected to be breast fed and get supplementary food using a cup and another to get supplementary food using a bottle.

The trial's inclusion criteria are: birth weight < 1500 g (very low birth weight infants), gestational age from 26 to 32 full weeks, absence of congenital anomalies in the face, head and neck, without severe asphyxia (Apgar < 5 on the 5th minute), negative tests for AIDS, absence of pulmonary chronic disease, mothers willing to breastfeed. Exclusion criteria are: intraventricular hemorrhage (degree III or IV), necrotizing enterocolitis, infection after the beginning of the trial.

Once all newborns in the trial were clinically stable (normal blood pressure without needs of oxygen) and with a volume intake of at least 100 ml/Kg/day of milk through the orogastric tube, they will receive oral-motor stimulation through a stimulation program previously published (2002). Once the newborn meets the criteria to begin oral feeding, an instrumental assessment of non-nutritive sucking and nutritive sucking will be carried out. Intra-oral pressure is assessed in non-nutritive sucking using a pressure monitoring device in a gloved finger: intra-oral negative pressure will be registered using a pressure transducer inserted through a catheter to the tip of the gloved little finger. This catheter will be connected to a second pressure transducer. Simultaneously, breathing (respiratory flow) will be measured using a pneumotachograph coupled to a nasal Prong. Two minutes of sucking will be collected from the moment the newborn responds to the search reflex and grabs the finger. During nutritive sucking assessment, respiration (respiratory flow) will be measured using a pneumotachograph coupled to a nasal Prong. At the same time intra-oral sucking pressure will be recorded by a pressure transducer connected to a catheter located on the mother's breast. Nutritive sucking will take place in the first 5 minutes of breastfeeding. After the first assessment has been concluded, the newborn will be randomly assigned either to the group that will use a cup or a bottle for supplementary feeding using randomized block design. Assessments will be repeated at discharge from the hospital.

The study is taking place at Fernandes Figueira Institute and was approved by the Institutional Review Board.

Being tested
cup feeding, bottle feeding
Keywords
Sucking patterns, preterm infants, breastfeeding
Medical subject headings
Breast Feeding

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cup feedingProcedure or surgery

    Also called cup method

    Method to feed: cup. This is a method to feed preterm babies when breastfeeding is impossible. Feed is provided using cup

  • bottle feedingProcedure or surgery

    Also called bottle

    bottle feeding This is a method to feed preterm babies when breastfeeding is impossible. Feed is provided using bottle

Study groups in NCT00703950
Study groupRoleWhat they receive
A,1ExperimentalCup feeding This is a method to feed preterm babies when breastfeeding is impossible. Feed is provided using cup
Receives: Procedure: cup feeding
A,2Active comparatorbottle feeding - conventional method Bottle feeding is the conventional method to feed preterm infant before breastfeeding or to substitute breastfeeding. We are using this method in the control group.
Receives: Procedure: bottle feeding

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Temporal parameters of sucking

    Measured: at discharge

Secondary outcomes (1)
  1. days of life at full oral feeding; breastfeeding rates at discharge days of life at full oral feeding breastfeeding rates at discharge

    Measured: at discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2008 (estimated)
  2. Study startJan 2008
  3. Primary completionMar 2013
  4. Study completionDec 2013

Why it stopped: Sample size was re- calculated considering sucking pattern parameters

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Single group
Masking
Single blind
Who is masked
Care provider
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00703950
Sponsor's protocol ID
CAAE-0288.0.008.000-05
Status last verified
Aug 2015
First submitted
2 Apr 2008
Last updated
11 Aug 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing cup feeding and bottle feeding in people with Infant, Very Low Birth Weight, run by Instituto Fernandes Figueira at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 11 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Sample size was re- calculated considering sucking pattern parameters). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Temporal parameters of sucking (time frame: at discharge). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2015.

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