Prebiotics for the prevention of hyperbilirubinaemia in neonates

Amir Mohammad Armanian; Shayesteh Jahanfar; Awat Feizi; Nima Salehimehr; Mitra Molaeinezhad; Erfan Sadeghi

doi:10.1002/14651858.CD012731.pub2

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Figure 1

Guidelines for phototherapy in infants at ≥ 35 weeks' gestation.

(American Academy of Pediatrics Subcommittee on Hyperbilirubinaemia. Management of hyperbilirubinaemia in the newborn infant 35 or more weeks of gestation. Pediatrics 2004;114:297.)

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Figure 2

Suggested guidelines for initiating phototherapy or exchange transfusion in preterm infants (< 35 weeks' gestation).

(Maisels MJ, Watchko JF, Bhutani VK, et al. An approach to the management of hyperbilirubinaemia in the preterm infant less than 35 weeks of gestation. Journal of Perinatology 2012;32:660‐664.)

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Figure 3

Study flow diagram.

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Figure 4

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

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Figure 5

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

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Analysis 1.1

Comparison 1 Feeding supplementation with prebiotics versus no prebiotics, Outcome 1 Incidence of hyperbilirubinaemia.

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Analysis 1.2

Comparison 1 Feeding supplementation with prebiotics versus no prebiotics, Outcome 2 Maximum plasma unconjugated bilirubin levels.

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Analysis 1.3

Comparison 1 Feeding supplementation with prebiotics versus no prebiotics, Outcome 3 Maximum plasma unconjugated bilirubin levels.

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Analysis 1.4

Comparison 1 Feeding supplementation with prebiotics versus no prebiotics, Outcome 4 Treatment with phototherapy.

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Analysis 1.5

Comparison 1 Feeding supplementation with prebiotics versus no prebiotics, Outcome 5 Stool frequency: gestational age.

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Analysis 1.6

Comparison 1 Feeding supplementation with prebiotics versus no prebiotics, Outcome 6 Stool frequency: birth weight.

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Analysis 1.7

Comparison 1 Feeding supplementation with prebiotics versus no prebiotics, Outcome 7 Stool frequency: type of prebiotic.

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Analysis 1.8

Comparison 1 Feeding supplementation with prebiotics versus no prebiotics, Outcome 8 Stool frequency: type of feeding.

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Analysis 1.9

Comparison 1 Feeding supplementation with prebiotics versus no prebiotics, Outcome 9 Duration of phototherapy (days).

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Analysis 1.10

Comparison 1 Feeding supplementation with prebiotics versus no prebiotics, Outcome 10 Length of hospital stay (days).

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Analysis 1.11

Comparison 1 Feeding supplementation with prebiotics versus no prebiotics, Outcome 11 Length of hospital stay (days).

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Analysis 1.12

Comparison 1 Feeding supplementation with prebiotics versus no prebiotics, Outcome 12 Neonatal mortality.

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Analysis 1.13

Comparison 1 Feeding supplementation with prebiotics versus no prebiotics, Outcome 13 Neonatal mortality.

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Summary of findings for the main comparison. Feeding supplementation with prebiotics compared to no prebiotics for the prevention of hyperbilirubinaemia in neonates

Feeding supplementation with prebiotics compared to no prebiotics for the prevention of hyperbilirubinaemia in neonates
Patient or population: Neonates, including term neonates (gestational age ≥ 37 weeks), late preterm neonates (35 to 37 weeks' gestation) and preterm neonates (< 35 weeks' gestation) Setting: Neonatal Intensive Care Units Intervention: Feeding supplementation with prebiotics Comparison: Distilled water/placebo or no supplementation
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Certainty of the evidence (GRADE)	Comments
	Risk with no prebiotics	Risk with Feeding supplementation with prebiotics
Incidence of hyperbilirubinaemia	Study population		RR 0.75 (0.58 to 0.97)	50 (1 RCT)	⊕⊕⊝⊝ LOW ^{a b}
	960 per 1,000	720 per 1,000 (557 to 931)
Maximum plasma unconjugated bilirubin levels; assessed with: mg/dL Scale from: 1 to 25	The mean maximum plasma unconjugated bilirubin levels; ranged from 7.6 to 8.1 mg/dL	MD 0.14 mg/dL higher (0.91 lower to 1.2 higher)	‐	78 (2 RCTs)	⊕⊕⊝⊝ LOW ^{a c}
Treatment with phototherapy	Study population		RR 0.75 (0.58 to 0.97)	50 (1 RCT)	⊕⊕⊝⊝ LOW ^{a b}
	960 per 1,000	720 per 1,000 (557 to 931)
Stool frequency	The mean stool frequency; ranged from 1 to 3	MD 1.18 higher (0.9 higher to 1.46 higher)	‐	154 (3 RCTs)	⊕⊕⊕⊕ HIGH
Duration of phototherapy (days)	The mean duration of phototherapy (days); ranged from 2 to 3 days	MD 0.1 days higher (2 lower to 2.2 higher)	‐	28 (1 RCT)	⊕⊕⊝⊝ LOW ^{b d}
Length of hospital stay (days)	The mean length of hospital stay (days); ranged from 29 to 72 days	MD 10.57 days lower (17.81 lower to 3.33 lower)	‐	78 (2 RCTs)	⊕⊕⊝⊝ LOW ^{a c}
Neonatal mortality	Study population		RR 0.94 (0.14 to 6.19)	78 (2 RCTs)	⊕⊕⊝⊝ LOW ^{a c}
	26 per 1,000	25 per 1,000 (4 to 163)
Acute bilirubin encephalopathy (encephalopathy)	Study population		not estimable	(0 RCTs)	‐	None of the included studies showed any acute bilirubin encephalopathy.
	0 per 1,000	0 per 1,000 (0 to 0)
Exchange transfusion (exchange)	Study population		not estimable	(0 RCTs)	‐	There were no reports of the need for exchange transfusion in included studies.
	0 per 1,000	0 per 1,000 (0 to 0)
Chronic bilirubin encephalopathy or kernicterus (kernicterus)	Study population		not estimable	(0 RCTs)	‐	There were no reports of the incidence of chronic bilirubin encephalopathy in included studies.
	0 per 1,000	0 per 1,000 (0 to 0)
Major neurodevelopmental disability	Study population		not estimable	(0 RCTs)	‐	Major neurodevelopmental disability was not reported in any of the included studies.
	0 per 1,000	0 per 1,000 (0 to 0)
Side effects	Study population		not estimable	(0 RCTs)	‐	No side effects were reported in any of the included studies.
	0 per 1,000	0 per 1,000 (0 to 0)
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio; OR: Odds ratio;
GRADE Working Group grades of evidence High certainty: We are very confident that the true effect lies close to that of the estimate of the effect Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
^a Downgraded one level due to high risk of performance bias ^b Downgraded one level due to uncertainty about precision (one study) ^c Downgraded one level due to uncertainty about precision (small study) ^d Downgraded one level due to unclear risk of attrition bias (incomplete outcome data)

Summary of findings for the main comparison. Feeding supplementation with prebiotics compared to no prebiotics for the prevention of hyperbilirubinaemia in neonates

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Comparison 1. Feeding supplementation with prebiotics versus no prebiotics

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Incidence of hyperbilirubinaemia Show forest plot	1	50	Risk Ratio (M‐H, Fixed, 95% CI)	0.75 [0.58, 0.97]

1.1 gestational age preterm neonates (< 35 weeks' gestation); birth weight ( < 1500 grams); type of prebiotic (oligosaccharide); type of feeding (only breast milk‐fed infants)	1	50	Risk Ratio (M‐H, Fixed, 95% CI)	0.75 [0.58, 0.97]
2 Maximum plasma unconjugated bilirubin levels Show forest plot	2	78	Mean Difference (IV, Fixed, 95% CI)	0.14 [‐0.91, 1.20]

2.1 gestational age preterm neonates (< 35 weeks' gestation), birth weight ( < 1500 grams)	2	78	Mean Difference (IV, Fixed, 95% CI)	0.14 [‐0.91, 1.20]
3 Maximum plasma unconjugated bilirubin levels Show forest plot	2	78	Mean Difference (IV, Fixed, 95% CI)	0.14 [‐0.91, 1.20]

3.1 breastfed only infants, oligosaccharide	1	50	Mean Difference (IV, Fixed, 95% CI)	‐0.90 [‐2.28, 0.48]
3.2 given a mixed form of feeding, lactulose	1	28	Mean Difference (IV, Fixed, 95% CI)	1.60 [‐0.03, 3.23]
4 Treatment with phototherapy Show forest plot	1	50	Risk Ratio (M‐H, Fixed, 95% CI)	0.75 [0.58, 0.97]

4.1 gestational age preterm neonates (< 35 weeks' gestation); birth weight ( < 1500 grams); type of prebiotic (oligosaccharide); type of feeding (only breast milk‐fed infants)	1	50	Risk Ratio (M‐H, Fixed, 95% CI)	0.75 [0.58, 0.97]
5 Stool frequency: gestational age Show forest plot	3	154	Mean Difference (IV, Fixed, 95% CI)	1.18 [0.90, 1.46]

5.1 term neonates (gestational age ≥ 37 weeks)	1	76	Mean Difference (IV, Fixed, 95% CI)	1.7 [1.34, 2.06]
5.2 preterm neonates (< 35 weeks' gestation)	2	78	Mean Difference (IV, Fixed, 95% CI)	0.4 [‐0.05, 0.85]
6 Stool frequency: birth weight Show forest plot	3	154	Mean Difference (IV, Fixed, 95% CI)	1.18 [0.90, 1.46]

6.1 infants ≥ 2500 grams	1	76	Mean Difference (IV, Fixed, 95% CI)	1.7 [1.34, 2.06]
6.2 infants < 1500 grams	2	78	Mean Difference (IV, Fixed, 95% CI)	0.4 [‐0.05, 0.85]
7 Stool frequency: type of prebiotic Show forest plot	3	154	Mean Difference (IV, Fixed, 95% CI)	1.18 [0.90, 1.46]

7.1 oligosaccharide	2	126	Mean Difference (IV, Fixed, 95% CI)	1.28 [0.98, 1.58]
7.2 lactulose	1	28	Mean Difference (IV, Fixed, 95% CI)	0.40 [‐0.44, 1.24]
8 Stool frequency: type of feeding Show forest plot	3	154	Mean Difference (IV, Fixed, 95% CI)	1.18 [0.90, 1.46]

8.1 breastfed only infants	1	50	Mean Difference (IV, Fixed, 95% CI)	0.40 [‐0.13, 0.93]
8.2 formula‐fed only infants	1	76	Mean Difference (IV, Fixed, 95% CI)	1.7 [1.34, 2.06]
8.3 given a mixed form of feeding	1	28	Mean Difference (IV, Fixed, 95% CI)	0.40 [‐0.44, 1.24]
9 Duration of phototherapy (days) Show forest plot	1	28	Mean Difference (IV, Fixed, 95% CI)	0.10 [0.00, 2.20]

9.1 gestational age preterm neonates (< 35 weeks' gestation); birth weight ( < 1500 grams); type of prebiotic (lactulose); type of feeding (infants given a mixed form of feeding)	1	28	Mean Difference (IV, Fixed, 95% CI)	0.10 [0.00, 2.20]
10 Length of hospital stay (days) Show forest plot	2	78	Mean Difference (IV, Fixed, 95% CI)	‐10.57 [‐17.81, ‐3.33]

10.1 gestational age preterm neonates (< 35 weeks' gestation), birth weight ( < 1500 grams)	2	78	Mean Difference (IV, Fixed, 95% CI)	‐10.57 [‐17.81, ‐3.33]
11 Length of hospital stay (days) Show forest plot	2	78	Mean Difference (IV, Fixed, 95% CI)	‐10.57 [‐17.81, ‐3.33]

11.1 breastfed only infants, oligosaccharide	1	50	Mean Difference (IV, Fixed, 95% CI)	‐10.2 [‐17.59, ‐2.81]
11.2 given a mixed form of feeding, lactulose	1	28	Mean Difference (IV, Fixed, 95% CI)	‐19.10 [‐54.58, 16.38]
12 Neonatal mortality Show forest plot	2	78	Risk Ratio (M‐H, Fixed, 95% CI)	0.94 [0.14, 6.19]

12.1 gestational age preterm neonates (< 35 weeks' gestation), birth weight ( < 1500 grams)	2	78	Risk Ratio (M‐H, Fixed, 95% CI)	0.94 [0.14, 6.19]
13 Neonatal mortality Show forest plot	2	78	Risk Ratio (M‐H, Fixed, 95% CI)	0.94 [0.14, 6.19]

13.1 breastfed only infants, oligosaccharide	1	50	Risk Ratio (M‐H, Fixed, 95% CI)	3.0 [0.13, 70.30]
13.2 given a mixed form of feeding, lactulose	1	28	Risk Ratio (M‐H, Fixed, 95% CI)	0.29 [0.01, 6.60]

Comparison 1. Feeding supplementation with prebiotics versus no prebiotics

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