EAL

BF: Artificial Nipple and Duration of Breastfeeding (2008)

Citation:

Mosley C, Whittle C, Hicks C. A pilot study to assess the viability of a randomised controlled trial of methods of supplementary feeding of breast-fed pre-term babies. Midwifery, 2001; 17: 150-157.

PubMed ID: 11399136

Study Design:

Randomized Controlled Trial

Class:

A - Click here for explanation of classification scheme.

Quality Rating:

NEGATIVE: See Quality Criteria Checklist below.

Research Purpose:

To compare the impact of two methods of supplementary feeding of pre-term babies (bottle vs. cup) on subsequent breastfeeding
To assess the feasibility of using an RCT to investigate this topic.

Inclusion Criteria:

Admission to special care baby unit during identified three-month period
Mother expressed desire to breastfeed
Mother between 30 weeks to 37 weeks gestation at birth
No congenital abnormalities
No maternal preference for cup or bottle as method of supplementary feeding
No supplementary feed via bottle or cup prior to admission.

Exclusion Criteria:

Not reported.

Description of Study Protocol:

Recruitment

Letter sent to all parents expressing wish for baby to be breast-fed, allowing baby's admission to the special care baby unit (SCBU)
Midwifery staff discussed with participating parents the SCBU's policy concerning supplementary feeding, aims of project and procedures of study
Written informed consent obtained.

Design

Rrandomized controlled trial: Random assignment to supplementary feeding method (bottle vs. cup).

Blinding Used

Not reported.

Intervention

Random assignment to supplementary feeding method (bottle vs. cup).

Statistical Analysis

Significance level of 0.01; Fisher's exact probability test.

Data Collection Summary:

Timing of Measurements

Random allocation to cup or bottle group
When each participating baby was considered able to progress from gastric feeding, supplementary feed was given via bottle or cup, depending on group assignment. Staff recorded feed in feed chart (type, amount of milk at each feed and frequency of feeds).
Whether baby was breast-fed or not prior to discharge was recorded and amount of support for breastfeeding that mothers perceived they had from staff
Timing of intervention not discussed.

Dependent Variables

Subsequent breastfeeding (defined as the exclusive method of feeding).

Independent Variables

Method of supplementary feeding of breast milk (bottle vs. cup).

Control Variables

Random assignment to group; feedings and data collection performed in SCBU of hospital.

Description of Actual Data Sample:

Initial N

10 in each group (bottle and cup).

Attrition (Final N)

Eight in bottle, six in cup group.

Age

No data for moms
Babies (including two excluded from subsequent analysis in cup group)
- Bottle: Five females, three males and 35.5 weeks gestational age
- Cup: Three females, five males and 35.2 weeks gestational age.

Location

United Kingdom.

Summary of Results:

Method of supplementary feeding did not influence subsequent breastfeeding (P=0.594), as four out of six cup-fed and six out of eight bottle-fed babies were exclusively breast-fed prior to discharge
Use of a dummy pacifier did not affect subsequent breastfeeding (P=0.406), as five out of six cup-fed and five out of eight bottle-fed babies given dummy pacifiers were exclusively breast-fed prior to discharge
Type of delivery (P=0.720), prior success at breastfeeding (P=0.545) did not affect subsequent breastfeeding of a pre-term baby
Gestational age and subsequent breastfeeding of pre-term babies are not significantly related (P=0.594). Mother's level of perceived support and successful breastfeeding are not significantly related (P=0.455). Successful breastfeeding and the number of days until the first milk feeding are not significantly related (P=0.126).

Author Conclusion:

There is no real effect of the method of supplementary feeding and subsequent breastfeeding, though the overall levels of breastfeeding within this SCBU generally were higher than the national average (United Kingdom).

Funding Source:

Other:

not reported.

Reviewer Comments:

Funding source not disclosed
Timing and length of intervention not discussed
No data reported for infant weight gain
No data reported for frequency, number and volume of any feedings (supplementary or breast).

Quality Criteria Checklist: Primary Research
Relevance Questions
	1.	Would implementing the studied intervention or procedure (if found successful) result in improved outcomes for the patients/clients/population group? (Not Applicable for some epidemiological studies)	Yes
	2.	Did the authors study an outcome (dependent variable) or topic that the patients/clients/population group would care about?	Yes
	3.	Is the focus of the intervention or procedure (independent variable) or topic of study a common issue of concern to dieteticspractice?	Yes
	4.	Is the intervention or procedure feasible? (NA for some epidemiological studies)	Yes

Validity Questions
1.	Was the research question clearly stated?		Yes
	1.1.	Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified?	Yes
	1.2.	Was (were) the outcome(s) [dependent variable(s)] clearly indicated?	Yes
	1.3.	Were the target population and setting specified?	Yes
2.	Was the selection of study subjects/patients free from bias?		No
	2.1.	Were inclusion/exclusion criteria specified (e.g., risk, point in disease progression, diagnostic or prognosis criteria), and with sufficient detail and without omitting criteria critical to the study?	Yes
	2.2.	Were criteria applied equally to all study groups?	Yes
	2.3.	Were health, demographics, and other characteristics of subjects described?	No
	2.4.	Were the subjects/patients a representative sample of the relevant population?	No
3.	Were study groups comparable?		Yes
	3.1.	Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT)	Yes
	3.2.	Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline?	Yes
	3.3.	Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.)	Yes
	3.4.	If cohort study or cross-sectional study, were groups comparable on important confounding factors and/or were preexisting differences accounted for by using appropriate adjustments in statistical analysis?	N/A
	3.5.	If case control study, were potential confounding factors comparable for cases and controls? (If case series or trial with subjects serving as own control, this criterion is not applicable.)	N/A
	3.6.	If diagnostic test, was there an independent blind comparison with an appropriate reference standard (e.g., "gold standard")?	N/A
4.	Was method of handling withdrawals described?		Yes
	4.1.	Were follow-up methods described and the same for all groups?	N/A
	4.2.	Was the number, characteristics of withdrawals (i.e., dropouts, lost to follow up, attrition rate) and/or response rate (cross-sectional studies) described for each group? (Follow up goal for a strong study is 80%.)	Yes
	4.3.	Were all enrolled subjects/patients (in the original sample) accounted for?	Yes
	4.4.	Were reasons for withdrawals similar across groups?	Yes
	4.5.	If diagnostic test, was decision to perform reference test not dependent on results of test under study?	N/A
5.	Was blinding used to prevent introduction of bias?		No
	5.1.	In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate?	No
	5.2.	Were data collectors blinded for outcomes assessment? (If outcome is measured using an objective test, such as a lab value, this criterion is assumed to be met.)	N/A
	5.3.	In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded?	N/A
	5.4.	In case control study, was case definition explicit and case ascertainment not influenced by exposure status?	N/A
	5.5.	In diagnostic study, were test results blinded to patient history and other test results?	N/A
6.	Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described?		No
	6.1.	In RCT or other intervention trial, were protocols described for all regimens studied?	No
	6.2.	In observational study, were interventions, study settings, and clinicians/provider described?	N/A
	6.3.	Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect?	No
	6.4.	Was the amount of exposure and, if relevant, subject/patient compliance measured?	No
	6.5.	Were co-interventions (e.g., ancillary treatments, other therapies) described?	N/A
	6.6.	Were extra or unplanned treatments described?	N/A
	6.7.	Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups?	N/A
	6.8.	In diagnostic study, were details of test administration and replication sufficient?	N/A
7.	Were outcomes clearly defined and the measurements valid and reliable?		No
	7.1.	Were primary and secondary endpoints described and relevant to the question?	Yes
	7.2.	Were nutrition measures appropriate to question and outcomes of concern?	No
	7.3.	Was the period of follow-up long enough for important outcome(s) to occur?	No
	7.4.	Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures?	No
	7.5.	Was the measurement of effect at an appropriate level of precision?	No
	7.6.	Were other factors accounted for (measured) that could affect outcomes?	No
	7.7.	Were the measurements conducted consistently across groups?	Yes
8.	Was the statistical analysis appropriate for the study design and type of outcome indicators?		N/A
	8.1.	Were statistical analyses adequately described and the results reported appropriately?	No
	8.2.	Were correct statistical tests used and assumptions of test not violated?	No
	8.3.	Were statistics reported with levels of significance and/or confidence intervals?	Yes
	8.4.	Was "intent to treat" analysis of outcomes done (and as appropriate, was there an analysis of outcomes for those maximally exposed or a dose-response analysis)?	No
	8.5.	Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)?	No
	8.6.	Was clinical significance as well as statistical significance reported?	No
	8.7.	If negative findings, was a power calculation reported to address type 2 error?	Yes
9.	Are conclusions supported by results with biases and limitations taken into consideration?		Yes
	9.1.	Is there a discussion of findings?	Yes
	9.2.	Are biases and study limitations identified and discussed?	Yes
10.	Is bias due to study's funding or sponsorship unlikely?		???
	10.1.	Were sources of funding and investigators' affiliations described?	No
	10.2.	Was the study free from apparent conflict of interest?	???