Cochrane · intervention · CD003315

Feeding interventions for growth and development in infants with cleft lip, cleft palate or cleft lip and palate

Bessell, A, Hooper, L, Shaw, WC, et al. · Cochrane Database of Systematic Reviews · 2011 · Cochrane Library

Oral Health Oral and maxillofacial surgery3 versionsAMSTAR 2: not assessed

Full textEvery question was extracted from the full review (methods and results), not only its Summary of Findings table.

Questions

14

current version

GRADE rated

0

No studies

1

Included studies

5

as reported

No studies 1 · 7.1%Ungraded 13 · 92.9%Very low 0 · 0%Low 0 · 0%Moderate 0 · 0%High 0 · 0%

Ungraded means an effect was reported without a GRADE rating; it is not a gap. No studies means the review found nothing to answer the question. The six categories are a display order, not a score.

Review question

Element	Planned (methods)	Found (results)
Population	Babies born with cleft lip, cleft palate or cleft lip and palate up to the age of 6 months (from term). Babies with Pierre Robin sequence or other syndromes were not included.	Babies with cleft lip only (Darzi 1996), cleft palate or cleft lip and palate prior to closure (Brine 1994, Masarei 2007), clefts of lip/palate/lip and palate (Shaw 1999), or complete unilateral cleft lip and palate (Prahl 2005); age birth to 6 months; 37 to 101 babies per study.
Intervention	Modified bottles, cups, spoons, pumps, positions, techniques and/or teats (supplemental to or instead of breastfeeding); obturating plates; maternal advice and support.	Squeezable bottles (n=130); Breastfeeding post cleft-lip surgery (n=40); Passive maxillary plate (2 studies)
Comparison	Any other intervention, or unmodified equipment or advice.	Rigid bottles (n=130); Spoon-feeding (n=40); No plate
Outcomes	Primary: growth (weight until age 16, growth centiles to age 16, head circumference up to 12 months, length). Secondary: development; parental satisfaction.	Weight (n=5); Length (n=4); Head circumference (n=4); Duration of hospital stay (n=1); Quality of life/parental satisfaction (n=1); Reliability of feeding method/bottle modification (n=1); Energy and protein intake (n=1); Adverse events (n=2); Cost (n=1)
Study designs	Randomised controlled trials (RCTs), true or quasi methods of random allocation.	Randomised controlled trials (5 RCTs)
Timing	Interventions in the first 6 months from term; outcomes may be measured at any time including adulthood.	Follow-up 7 to 13 months up to 18 months; measurements to 12 to 18 months; breastfeeding weight at 6 weeks post-surgery; maxillary plate measured 2 to 12 months.

Search date: 2010-10. Databases: Cochrane Oral Health Group Trials Register; Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE via OVID (1950); EMBASE via OVID (1980); PsycINFO via OVID (1950); CINAHL via EBSCO (1980)

Questions and results

Current version only

Squeezable (modified) feeding bottle vs Rigid feeding bottle

Population: Infants up to 6 months (from term) born with cleft lip, cleft palate or cleft lip and palate (Pierre Robin sequence or other syndromes excluded)

CD003315.PUB3 (current) · 6 questions

Outcome	Effect	Evidence	Status / GRADE
Energy and protein intake 3 to 6 months same question in other reviews	Mean energy and protein intakes (Brine 1994): statistically significant difference for protein intake at 3 and 6 months in favour of the squeezable bottle (P < 0.05); possibly confounded by four infants receiving a…	1 study · 37 participants	Ungraded
Weight (kg) >6 months same question in other reviews	MD -0.15 [-0.53, 0.22]	2 studies · 130 participants	Ungraded
Reliability of feeding method (number of times bottle modified) up to 12 months same question in other reviews	Number of times a bottle had to be modified by the health visitor: 25/52 (48%) for rigid bottles versus 4/49 (8%) for squeezable bottles (Shaw 1999), P < 0.05 (favours squeezable). Six babies randomised to the rigid…	1 study · 101 participants	Ungraded
Length (cm) >6 months same question in other reviews	MD 0.21 [-0.72, 1.14]	2 studies · 130 participants	Ungraded
Quality of life and parental satisfaction (crying, feeding, sleeping, playing time; 24-hour parental log) up to 12 months same question in other reviews	Quality of life and adverse events (crying, feeding, sleeping and playing time, 24-hour parental log; Shaw 1999): no statistically significant differences between bottle types. Parental satisfaction also reported.	1 study · 101 participants	Ungraded
Head circumference (cm) >6 months same question in other reviews	MD -0.66 [-1.16, -0.17]	2 studies · 130 participants	Ungraded

Breastfeeding (post cleft-lip surgery) vs Spoon-feeding

Population: Infants up to 6 months (from term) born with cleft lip, cleft palate or cleft lip and palate (Pierre Robin sequence or other syndromes excluded)

CD003315.PUB3 (current) · 4 questions

Outcome	Effect	Evidence	Status / GRADE
Weight (kg) 6 weeks post-surgery same question in other reviews	MD 0.47 [0.20, 0.74]	1 study · 40 participants	Ungraded
Duration of hospital stay (days) post-surgery same question in other reviews	Duration of hospital stay (days): no statistically significant difference between the two groups (Darzi 1996); no pooled estimate displayed (totals not selected).	1 study · 40 participants	Ungraded
Adverse events (wound dehiscence; lip scar hypertrophy) post-surgery same question in other reviews	Adverse events: one wound dehiscence and one hypertrophy of the lip scar, both in spoon-fed infants (Darzi 1996).	1 study · 40 participants	Ungraded
Cost of hospitalisation post-surgery same question in other reviews	Average total cost of hospitalisation: 98 Indian rupees (breastfeeding) versus 156 Indian rupees (spoon-feeding) (Darzi 1996).	1 study · 40 participants	Ungraded

Passive maxillary/obturating plate (worn until surgical closure of soft palate) vs No plate

Population: Infants up to 6 months (from term) born with cleft lip, cleft palate or cleft lip and palate (Pierre Robin sequence or other syndromes excluded)

CD003315.PUB3 (current) · 3 questions

Outcome	Effect	Evidence	Status / GRADE
Weight (kg) 12 months (351 to 379 days) same question in other reviews	MD 0.10 [-0.53, 0.73]	2 studies · 50 participants	Ungraded
Head circumference (cm) 12 months same question in other reviews	MD 0.25 [-1.03, 1.53]	1 study · 32 participants	Ungraded
Length (cm) 2 to 6 months same question in other reviews	MD -1.05 [-2.20, 0.11]	2 studies · 74 participants	Ungraded

Maternal advice and support (feeding techniques/breastfeeding positions) vs Usual care (no additional advice/support)

Population: Infants up to 6 months (from term) born with cleft lip, cleft palate or cleft lip and palate (Pierre Robin sequence or other syndromes excluded)

CD003315.PUB3 (current) · 1 question

Outcome	Effect	Evidence	Status / GRADE
Outcome NR same question in other reviews	No trials were identified that examined the effect of additional maternal support or advice during breastfeeding (or bottle-feeding); no studies evaluated the effectiveness of this intervention (plain-language summary…	0 studies	No studies

Squeezable (modified) feeding bottle vs Rigid feeding bottle

Population: Infants up to 6 months (from term) born with cleft lip, cleft palate or cleft lip and palate (Pierre Robin sequence or other syndromes excluded)

CD003315.PUB2 · 6 questions

Outcome	Effect	Evidence	Status / GRADE
Weight (kg) >6 months	MD -0.02 [-0.88, 0.84]	2 studies · 130 participants	Ungraded
Head circumference (cm) >6 months	MD -0.41 [-1.68, 0.86]	2 studies · 130 participants	Ungraded
Energy and protein intake 3 to 6 months	Mean energy and protein intakes (Brine 1994): statistically significant difference for protein intake at 3 and 6 months in favour of the squeezable bottle (P < 0.05); possibly confounded by four infants in that group…	1 study · 37 participants	Ungraded
Length (cm) >6 months	MD 0.65 [-1.49, 2.78]	2 studies · 130 participants	Ungraded
Reliability of feeding method (number of times bottle modified) up to 12 months	Number of times a bottle had to be modified by the health visitor: 25/52 (48%) for rigid bottles versus 4/49 (8%) for squeezable bottles (Shaw 1999), P < 0.05 (favours squeezable). Six babies randomised to the rigid…	1 study · 101 participants	Ungraded
Quality of life and parental satisfaction (crying, feeding, sleeping, playing time; 24-hour parental log) up to 12 months	Quality of life and adverse events (crying, feeding, sleeping and playing time, measured with a 24-hour parental log; Shaw 1999): no statistically significant differences between bottle types for any of these outcomes.…	1 study · 101 participants	Ungraded

Breastfeeding (post cleft-lip surgery) vs Spoon-feeding

Population: Infants up to 6 months (from term) born with cleft lip, cleft palate or cleft lip and palate (Pierre Robin sequence or other syndromes excluded)

CD003315.PUB2 · 4 questions

Outcome	Effect	Evidence	Status / GRADE
Adverse events (wound dehiscence; lip scar hypertrophy) post-surgery	Adverse events: one wound dehiscence and one hypertrophy of the lip scar, both in spoon-fed infants (Darzi 1996). Spoon-fed infants also required analgesia/sedation and IV fluids more often (data not provided).	1 study · 40 participants	Ungraded
Weight (kg) 6 weeks post-surgery	MD 0.47 [0.20, 0.74]	1 study · 40 participants	Ungraded
Cost of hospitalisation post-surgery	Average total cost of hospitalisation: 98 Indian rupees (breastfeeding) versus 156 Indian rupees (spoon-feeding) (Darzi 1996); increase attributed to additional analgesia/sedation and commercial feeds.	1 study · 40 participants	Ungraded
Duration of hospital stay (days) post-surgery	Duration of hospital stay (days): no statistically significant difference between the two groups (Darzi 1996); no pooled estimate displayed (totals not selected).	1 study · 40 participants	Ungraded

Passive maxillary/obturating plate (worn until surgical closure of soft palate) vs No plate

Population: Infants up to 6 months (from term) born with cleft lip, cleft palate or cleft lip and palate (Pierre Robin sequence or other syndromes excluded)

CD003315.PUB2 · 2 questions

Outcome	Effect	Evidence	Status / GRADE
Length (cm) 2 to 12 months	Length z-scores (Prahl in press/2005): no statistically significant differences between groups. No pooled mean difference displayed (totals not selected).	1 study · 40 participants	Ungraded
Weight (kg) 2 to 12 months	One study (Prahl in press/2005): 54 babies randomised, 40 with sufficient anthropometric measurements. Weight reported as weight-for-length, length-for-age and weight-for-age z-scores; no statistically significant…	1 study · 40 participants	Ungraded

Maternal advice and support (feeding techniques/breastfeeding positions) vs Usual care (no additional advice/support)

Population: Infants up to 6 months (from term) born with cleft lip, cleft palate or cleft lip and palate (Pierre Robin sequence or other syndromes excluded)

CD003315.PUB2 · 1 question

Outcome	Effect	Evidence	Status / GRADE
Outcome NR	No trials were identified that examined the effect of additional maternal support or advice during breastfeeding (or bottle-feeding). No evidence was found to assess the use of any types of maternal advice and/or…	0 studies	No studies

Modified/squeezable feeding bottle or teat vs Unmodified (rigid) bottle or equipment

Population: Infants up to 6 months (from term) born with cleft lip, cleft palate or cleft lip and palate (Pierre Robin sequence or other syndromes excluded)

CD003315 · 1 question

Outcome	Effect	Evidence	Status / GRADE
Outcome NR Any time including adulthood (planned)	no estimate extracted	0 studies	No studies

Breastfeeding / supplemental breastfeeding vs Alternative feeding method (e.g. spoon-feeding)

Population: Infants up to 6 months (from term) born with cleft lip, cleft palate or cleft lip and palate (Pierre Robin sequence or other syndromes excluded)

CD003315 · 1 question

Outcome	Effect	Evidence	Status / GRADE
Outcome NR Any time including adulthood (planned)	no estimate extracted	0 studies	No studies

Obturating/maxillary plate vs No plate

Population: Infants up to 6 months (from term) born with cleft lip, cleft palate or cleft lip and palate (Pierre Robin sequence or other syndromes excluded)

CD003315 · 1 question

Outcome	Effect	Evidence	Status / GRADE
Outcome NR Any time including adulthood (planned)	no estimate extracted	0 studies	No studies

Maternal advice and support vs Usual care (no additional advice/support)

Population: Infants up to 6 months (from term) born with cleft lip, cleft palate or cleft lip and palate (Pierre Robin sequence or other syndromes excluded)

CD003315 · 1 question

Outcome	Effect	Evidence	Status / GRADE
Outcome NR Any time including adulthood (planned)	no estimate extracted	0 studies	No studies