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Cochrane Database of Systematic Reviews Protocol - Intervention

Cup feeding versus other forms of supplemental enteral feeding for newborn infants unable to fully breastfeed

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Abstract

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:

To determine the effects on weight gain and achievement of successful breast‐feeding of cup feeding versus other forms of supplemental enteral feeding in newborn infants that are unable to fully breastfeed.

To determine if outcomes differ by:

Population:

  • born preterm (less than 37 weeks gestation) versus term (greater than or equal to 37 weeks gestation)

  • born with oral‐facial abnormalities such as a cleft lip and/or cleft palate versus no oral‐facial abnormalities

Background

Whilst it is recognised that the optimal milk for newborn infants is their mother's breast milk, and the best way for them to achieve this is by sucking on the breast, there are numerous reasons why a baby may not be able to breastfeed. If a newborn infant cannot breastfeed then an alternative form of enteral feeding is required. Alternatives include gastric tube feeding, bottle‐feeding and cup feeding.

Traditionally bottles and gastric tubes have been used routinely in neonatal units to feed infants who are unable to fully breastfeed, particularly at night and when mothers are unable to be present for all feeds (Lang 1994b). Whilst this may not be wanted by either staff or mothers, there are limited options for an unsettled infant when the mother is not available to breastfeed and gastric tube feeding does not satisfy the infant's psychological and social needs (Lang 1994b). Cup feeding has been suggested as an alternative.

It is argued that because cup feeding only requires the infant to 'lap' the milk and then coordinate swallowing and breathing, the preterm infant can be fed using a cup from as early as 30 weeks gestation. This is well before the time that breast and bottle feeding can be introduced as this requires the coordination of sucking, swallowing and breathing which are often uncoordinated until approximately 32‐35 weeks of age (Lang 1994a; Lang 1994b; Palmer 1993) . Artificial feeding methods consisting of pap bowls, feeding horns, cups with lips and bottles have existed throughout history (Lang 1994a). Originally cup feeding was used to feed newborns who were born with oral deformities such as a cleft lip or cleft palate (Fredeen 1948). Cup feeding has been used in developing countries for several decades where the care and hygiene facilities for bottles and teats have been limited and gastric tubes are not readily available (Dowling 2002; Lang 1994b). More recently cup feeding is gaining increased use as an alternative feeding method in maternity and neonatal units for preterm and term infants who are unable to fully breastfeed (NANN 2004). The theoretical benefits are said to include avoiding the confusion between breast and bottle (Dowling 2002; Gupta 1999; Thorley 1997); enhancing the newborn's ability to develop a suckling action for breastfeeding (Thorley 2004) and to facilitate the newborn's ability to self regulate feeds and demand feeds (Vallenas 1998). The Baby Friendly Hospital Initiative (BFHI) training literature and guideline recommends the use of cup feeding for infants intending to be breast fed, so that no artificial teats are introduced to these infants (Lang 1994b; Vallenas 1998).

The literature suggests that there are many advantages and positives of cup feeding (Cousins 1999; Fredeen 1948; Gupta 1999; Kuehl 1997; Lang 1994a; Lang 1994b). These include that cup feeding is a simple procedure that can involve both parents; early positive body and eye contact is fostered; the infant receives positive tactile and olfactory stimulation; cardio‐respiratory and oxygen saturations can be maintained whilst cup feeding (Dowling 2002; Lang 1994a; Lang 1994b); the infant controls the feed and can pace its own intake and the total volume of milk taken; there is minimal risk of aspiration and minimal energy expended by the preterm infant (Lang 1994a; Lang 1994b; Thorley 2004). Many of these advantages however could also be claimed of bottle feeding.

Whilst there may be many benefits of feeding preterm and term infants via a cup, there are also potential risks (NANN 2004) which need to be considered when introducing this practice into maternity and neonatal units. Some authors have reported that cup feeding is awkward at first and the infant is at risk of aspiration pneumonia when the improper technique is used resulting in the milk being 'poured into' the infants mouth rather than allowing the infant to 'lap' or sip the milk (Lang 1994b; Thorley 2004). Other potential risks include physiological instability (bradycardia, apnoea, low oxygen saturations) (Freer 1999), choking and poor weight gain (Kuehl 1997), which can result in extended hospitalisation and add to cost of care. Lastly, undesirable outcomes have been reported: nursing workload may be increased as a result of extra nursing time needed to cup feed, and term infants may refuse the breast, become addicted to the cup if use is prolonged and they are not given the opportunity to breastfeed (Lang 1994b; Thorley 1997; Thorley 2004). If infants require treatment as a result of an adverse event or if term infants reject the breast, this may result in increased stress and anxiety to the parents and family.

Before the introduction of cup feeding into neonatal nurseries the practice must be evaluated for efficiency in terms of clinical outcomes, human resource use, cost and time: the benefits must outweigh the harms.

Objectives

To determine the effects on weight gain and achievement of successful breast‐feeding of cup feeding versus other forms of supplemental enteral feeding in newborn infants that are unable to fully breastfeed.

To determine if outcomes differ by:

Population:

  • born preterm (less than 37 weeks gestation) versus term (greater than or equal to 37 weeks gestation)

  • born with oral‐facial abnormalities such as a cleft lip and/or cleft palate versus no oral‐facial abnormalities

Methods

Criteria for considering studies for this review

Types of studies

Randomised or quasi‐randomised controlled trials in which newborn infants that are unable to fully breastfeed were allocated to a policy of cup feeding versus other forms of supplemental enteral feeding. Crossover studies will be excluded.

Types of participants

Newborn infants up to a corrected age of 44 weeks or 28 days postnatal age that are unable to fully breastfeed.

Types of interventions

Oral feeding of either expressed breast milk or a combination of expressed breast milk and artificial formula via a cup (or of a similar design so that the infant 'laps' the milk) versus other forms of supplemental enteral feeding (such as tube feeds and bottle feeds).

Types of outcome measures

Primary:
Weight gain (g/kg/day)

  • Time to full breastfeeding with acceptable weight gain (15‐30 grams/day)

  • Proportion not breastfeeding at hospital discharge and at three and six months of age

  • Proportion not fully breastfeeding at hospital discharge and at three and six months of age

Secondary:

  • Average time per feed (minutes)

  • Number of reported choking events per infant or per cup feed over the duration of cup feeding period depending on how described in individual studies

  • Number of reported aspiration events per infant or per cup feed over the duration of cup feeding period depending on how described in individual studies

  • Number of reported infection events per infant or per cup feed over the duration of cup feeding period depending on how described in individual studies

  • Number of reported physiological instability events i.e. bradycardia, apnoea, low oxygen saturations per infant or per cup feed over the duration of cup feeding period depending on how described in individual studies

  • Postnatal age at discharge (days)

  • Length of hospital stay (days)

  • Cost ($)

  • Parental satisfaction (however assessed in individual studies)

  • Parental anxiety (however assessed in individual studies)

  • Neuro‐developmental outcomes at 18 and 24 months of age (e.g.. Bayley's; Griffiths)

  • Death prior to discharge if reported

  • Death by 28 days of age if reported

  • Death by 12 months of age if reported

Search methods for identification of studies

The standard search strategy for the Cochrane Neonatal Review Group will be used. See: Neonatal Review Group search strategy. This includes searches of electronic databases: The Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, the latest issue); CINAHL from 1987; and MEDLINE from 1966.
Searches of the electronic databases will be based on the following search terms:

The MeSH terms 'Infant, Newborn' OR 'Nurseries, Hospital' OR 'Intensive Care Units, Neonatal'
AND
The textword "cup"

We will also search previous reviews including cross‐references, abstracts, conference and symposia proceedings, expert informants, journal hand searching in the English language. No other language restrictions will apply.
The title and abstract of each retrieved study will be examined to assess eligibility. If there is uncertainty, the full paper will be examined.

Data collection and analysis

Criteria and methods used to assess the methodological quality of the trials: standard methods of the Cochrane Collaboration (Alderson 2004) and its Neonatal Review Group will be used. At least two of the reviewers will work independently to search for and assess trials for inclusion and methodological quality. Studies will be assessed using the following key criteria: allocation concealment (blinding of randomisation), blinding of intervention, completeness of follow up and blinding of outcome measurement assigning a rating of 'Yes', 'No' or 'Can't tell' for each. The reviewers will extract data independently. Differences will be resolved by discussion. An attempt will be made to contact study investigators for additional information or data as required.

Data analysis:
For individual trials: for continuous variables such as weight gain, mean differences, and 95% confidence intervals will be reported. For categorical outcomes such as mortality, the relative risks (RR) and 95% confidence intervals will be reported.

For pooled results: for continuous variables, weighted mean differences (WMD) and 95% confidence intervals will be reported. For categorical outcomes, the relative risks (RR) and 95% confidence intervals will be reported. For significant findings, the risk difference (RD) and number needed to treat (NNT) will also be reported. Each treatment effect will be tested for heterogeneity to help determine suitability for pooling of results in a meta‐analysis. The fixed effects model will be used for meta‐analysis. If there are sufficient included studies heterogeneity will be assessed using two statistics (H and I squared test) of heterogeneity, which are thought to be better at quantifying the heterogeneity than the chi‐squared test (Higgins 2002). Where statistical heterogeneity is found the reviewers will look for an explanation. If studies with heterogenous results are thought to be comparable, a random effects model will be used to combine the data.

Data permitting a sensitivity analysis will be performed to see if results differ by quality of included studies i.e.. adequacy of randomisation ‐ quasi randomised versus randomised.