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.
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
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.
- Conditions
- Infant, Very Low Birth Weight
- 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 group | Role | What they receive |
|---|---|---|
| A,1 | Experimental | Cup feeding This is a method to feed preterm babies when breastfeeding is impossible. Feed is provided using cup Receives: Procedure: cup feeding |
| A,2 | Active comparator | bottle 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.
Temporal parameters of sucking
Measured: at discharge
Secondary outcomes (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.
- First posted24 Jun 2008 (estimated)
- Study startJan 2008
- Primary completionMar 2013
- Study completionDec 2013
Why it stopped: Sample size was re- calculated considering sucking pattern parameters
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant, Very Low Birth WeightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Instituto Fernandes Figueira
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Maria Elisabeth Lopes Moreira, Instituto Fernandes Figueira
- Investigators
- Maria Elisabeth l Moreira, PhD, Principal investigator, Instituto Fernandes Figueira
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Use of a Bottle and a Cup on Breast Sucking Patterns of Premature Infants: Safety and Efficacy
- ClinicalTrials.gov ID
- NCT00703950
- Acronym / sponsor ID
- CAAE-0288.0.008.000-05
- Conditions
- Infant, Very Low Birth Weight
- Keywords
- Sucking patterns, preterm infants, breastfeeding
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sample size was re- calculated considering sucking pattern parameters
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Instituto Fernandes FigueiraOther government
- Study start
- Jan 2008
- Primary completion
- Mar 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 24 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A,1 | Experimental | Procedure: cup feedingCup feeding This is a method to feed preterm babies when breastfeeding is impossible. Feed is provided using cup |
| A,2 | Active comparator | Procedure: bottle feedingbottle 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. |
Who may qualify
- Ages
- 29 to 33 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- severe intraventricular hemorrhage
- necrotizing enterocolitis
- infection after the beginning of the trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cup feedingAlso: cup methodMethod to feed: cup. This is a method to feed preterm babies when breastfeeding is impossible. Feed is provided using cup | Procedure or surgery | A,1 |
| bottle feedingAlso: bottlebottle feeding This is a method to feed preterm babies when breastfeeding is impossible. Feed is provided using bottle | Procedure or surgery | A,2 |
Primary outcome
Temporal parameters of sucking
Time frame: at discharge
1 secondary outcome
days of life at full oral feeding; breastfeeding rates at discharge days of life at full oral feeding breastfeeding rates at discharge
Time frame: at discharge
Results and safety
The study was stopped early (reason given: Sample size was re- calculated considering sucking pattern parameters). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Elisabeth l Moreira, PhD principal investigator
Instituto Fernandes Figueira
1 site in 1 country: see every site and its status.
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.