Sucking Pattern of Preterm Infants Using Cup or Bottle Before Breastfeeding

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Instituto Fernandes Figueira.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Maria Elisabeth Lopes Moreira, Instituto Fernandes Figueira
ClinicalTrials.gov Identifier:
NCT00703950
First received: April 2, 2008
Last updated: March 29, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Infant, Very Low Birth Weight
Procedure: cup feeding
Procedure: bottle feeding
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Supportive Care
Official Title: Effects of the Use of a Bottle and a Cup on Breast Sucking Patterns of Premature Infants: Safety and Efficacy

Resource links provided by NLM:


Further study details as provided by Instituto Fernandes Figueira:

Primary Outcome Measures:
  • Temporal parameters of sucking [ Time Frame: at discharge ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 96
Study Start Date: January 2008
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A,1
Cup feeding
Procedure: cup feeding
Method to feed: cup. Nowadays, this is a alternative method to feed preterm infant. However there is no evidence that is a safe method to feed preterm infant.
Other Name: cup method
Active Comparator: A,2
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.
Procedure: bottle feeding
bottle feeding
Other Name: bottle

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.

  Eligibility

Ages Eligible for Study:   29 Weeks to 33 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • severe intraventricular hemorrhage
  • necrotizing enterocolitis
  • infection after the beginning of the trial
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00703950

Contacts
Contact: Maria Elisabeth Moreira, PhD 55-21-2554-1796 bebeth@iff.fiocruz.br
Contact: Adriana Rocha, MS 55-21-2554-1733 rochachirol@gmail.com

Locations
Brazil
Instituto Fernandes Figueira Recruiting
Rio de Janeiro, RJ, Brazil, 22250020
Contact: Maria Elisabeth Moreira, PhD    55-21-2554-1796    bebeth@iff.fiocruz.br   
Sub-Investigator: Adriana D Rocha, MS         
Principal Investigator: Maria Elisabeth L Moreira, PhD         
Sponsors and Collaborators
Instituto Fernandes Figueira
Investigators
Principal Investigator: Maria Elisabeth l Moreira, PhD Instituto Fernandes Figueira
  More Information

No publications provided

Responsible Party: Maria Elisabeth Lopes Moreira, MD, Instituto Fernandes Figueira
ClinicalTrials.gov Identifier: NCT00703950     History of Changes
Other Study ID Numbers: CAAE-0288.0.008.000-05
Study First Received: April 2, 2008
Last Updated: March 29, 2012
Health Authority: Brazil: National Committee of Ethics in Research
United States: Federal Government

Keywords provided by Instituto Fernandes Figueira:
Sucking patterns
preterm infants
breastfeeding

Additional relevant MeSH terms:
Birth Weight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 26, 2014