BreastfeedingNCT00756587
Cup Versus Bottle Feeding for Late Preterm Infants
A study testing Cup Feeding and Bottle Feeding in people with Breastfeeding, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of the current study is to investigate the effect of using cup feeding for preterm infants during NICU stay on breastfeeding outcomes after discharge. The following hypotheses are being tested: 1. Infants Fed by cup during NICU stay will have higher breastfeeding proportions than infants fed by bottle 2. Read more about this study
- Who is it for?
- Ages 34 to 37 weeks
- Conditions the study is for
- Breastfeeding
- What is being tested?
- Cup Feeding and Bottle Feeding
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- Dec 2003to Aug 2004
- Phase
- Interventional
- 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 34 to 37 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Singleton birth
- 34 to 37 weeks of gestation at birth
- Maternal intention to breastfeed
- Fed only by tube feeding
Who cannot join
- Infants who had any condition interfering with oral feeding
- Infants with craniofacial anomalies
- Infants with intracranial hemorrhage
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cup Versus Bottle Feeding for Hospitalized Late Preterm Infants in Egypt
The purpose of the current study is to investigate the effect of using cup feeding for preterm infants during NICU stay on breastfeeding outcomes after discharge. The following hypotheses are being tested:
- Infants Fed by cup during NICU stay will have higher breastfeeding proportions than infants fed by bottle
- Infants fed by cup during NICU stay will have higher breastfeeding behaviour score on the Preterm Infant Breastfeeding Behavior Scale than infants fed by bottle
Read the detailed description
The provision of breast milk is essential for preterm infants as it provides unique health benefits that are unmatched by other types of feeding [1-3]. However, breastfeeding presents unique challenges for preterm infants that include establishing and maintaining the mothers' milk supply and transitioning the infant from gavage feeding to breastfeeding [4]. One of the issues that presents during the transition to breastfeeding is that mothers of preterm infants are rarely available for all oral feedings during hospitalization; this makes it necessary for infants to receive oral feedings by other method, usually bottle feeding.
However, exposure of newborn infants to artificial nipples has been strongly associated with breastfeeding problems [5-9]. Frequently these problems have been explained by phenomena called nipple confusion. Nipple confusion occurs when infants are exposed to two different feeding methods, bottle and breast, resulting in the infant refusing to breastfeed. Consequently, it has been recommended that bottle feeding be avoided and that cup feeding be used for the supplementation of term as well as preterm infants.
Cup feeding is known as an alternative method of feeding breast milk to an infant using a small cup without a lip. Cup feeding is also recommended by the Baby Friendly Hospital Initiative.The use of cup was originally based on the goal of avoiding propping of bottles and also to increase bodily contact with the mother during feeding. Although cup feeding receives little mention in medical literature, and may seem to be a new technique for some, it has been used in several developing as well as developed countries. Lang, who observed cup feeding in South Nepal, implemented cup feeding in England and the practice expanded to other developed countries. Consequently cup feeding was established as a method for feeding infants who could not be breastfed from birth.
- Conditions
- Breastfeeding
- Being tested
- Cup Feeding, Bottle Feeding
- Keywords
- Cup Feeding, late Preterm
- 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 FeedingDevice
Also called Cup-feeding Group
using a cup feeding technique for feeding the preterm infants during NICU stay
Bottle FeedingDevice
Also called bottle feeding group
receiving all feeding by bottle
| Study group | Role | What they receive |
|---|---|---|
| I | Active comparator | Group one received feeding by bottle as the standard method of feeding in the NICU Receives: Device: Bottle Feeding |
| II | Experimental | Group 2 received all feeding by cup Receives: Device: Cup Feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breastfeeding Proportion
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2008 (estimated)
- Study startDec 2003
- Primary completionAug 2004
- Study completionAug 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Investigators
- Amel M Abouelfettoh, PhD, RN, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00756587
- Sponsor's protocol ID
- 2004
- Status last verified
- Sep 2008
- First submitted
- 19 Sep 2008
- Last updated
- 31 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Abouelfettoh AM, Dowling DA, Dabash SA, Elguindy SR, Seoud IA. Cup versus bottle feeding for hospitalized late preterm infants in Egypt: a quasi-experimental study. Int Breastfeed J. 2008 Nov 21;3:27. doi: 10.1186/1746-4358-3-27.
PubMed 19025602
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cup Versus Bottle Feeding for Hospitalized Late Preterm Infants in Egypt
- ClinicalTrials.gov ID
- NCT00756587
- Acronym / sponsor ID
- 2004
- Conditions
- Breastfeeding
- Keywords
- Cup Feeding, late Preterm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Dec 2003
- Primary completion
- Aug 2004 (actual)
- Study completion
- Aug 2004 (actual)
- First posted
- 22 Sep 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 purpose of the current study is to investigate the effect of using cup feeding for preterm infants during NICU stay on breastfeeding outcomes after discharge. The following hypotheses are being tested:
- Infants Fed by cup during NICU stay will have higher breastfeeding proportions than infants fed by bottle
- Infants fed by cup during NICU stay will have higher breastfeeding behaviour score on the Preterm Infant Breastfeeding Behavior Scale than infants fed by bottle
Detailed description
The provision of breast milk is essential for preterm infants as it provides unique health benefits that are unmatched by other types of feeding [1-3]. However, breastfeeding presents unique challenges for preterm infants that include establishing and maintaining the mothers' milk supply and transitioning the infant from gavage feeding to breastfeeding [4]. One of the issues that presents during the transition to breastfeeding is that mothers of preterm infants are rarely available for all oral feedings during hospitalization; this makes it necessary for infants to receive oral feedings by other method, usually bottle feeding.
However, exposure of newborn infants to artificial nipples has been strongly associated with breastfeeding problems [5-9]. Frequently these problems have been explained by phenomena called nipple confusion. Nipple confusion occurs when infants are exposed to two different feeding methods, bottle and breast, resulting in the infant refusing to breastfeed. Consequently, it has been recommended that bottle feeding be avoided and that cup feeding be used for the supplementation of term as well as preterm infants.
Cup feeding is known as an alternative method of feeding breast milk to an infant using a small cup without a lip. Cup feeding is also recommended by the Baby Friendly Hospital Initiative.The use of cup was originally based on the goal of avoiding propping of bottles and also to increase bodily contact with the mother during feeding. Although cup feeding receives little mention in medical literature, and may seem to be a new technique for some, it has been used in several developing as well as developed countries. Lang, who observed cup feeding in South Nepal, implemented cup feeding in England and the practice expanded to other developed countries. Consequently cup feeding was established as a method for feeding infants who could not be breastfed from birth.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I | Active comparator | Device: Bottle FeedingGroup one received feeding by bottle as the standard method of feeding in the NICU |
| II | Experimental | Device: Cup FeedingGroup 2 received all feeding by cup |
Who may qualify
- Ages
- 34 to 37 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Singleton birth
- 34 to 37 weeks of gestation at birth
- Maternal intention to breastfeed
- Fed only by tube feeding
Key exclusion criteria (3 listed)
- Infants who had any condition interfering with oral feeding
- Infants with craniofacial anomalies
- Infants with intracranial hemorrhage
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-feeding Groupusing a cup feeding technique for feeding the preterm infants during NICU stay | Device | II |
| Bottle FeedingAlso: bottle feeding groupreceiving all feeding by bottle | Device | I |
Primary outcome
Breastfeeding Proportion
Time frame: one week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2008.
- Derived from this study: PubMed 19025602Abouelfettoh AM, Dowling DA, Dabash SA, Elguindy SR, Seoud IA. Cup versus bottle feeding for hospitalized late preterm infants in Egypt: a quasi-experimental study. Int Breastfeed J. 2008 Nov 21;3:27. doi: 10.1186/1746-4358-3-27.
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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.
Amel M Abouelfettoh, PhD, RN principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cup Feeding and Bottle Feeding in people with Breastfeeding, run by Cairo University at 1 site in Egypt.
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 4 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: finished, as of the sponsor's last update on 31 Oct 2008. 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 Egypt. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Breastfeeding Proportion (time frame: one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00756587, which also lists 1 linked publication.
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 31 Oct 2008.