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Early additional food and fluids for healthy breastfed full‐term infants

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Abstract

Background

Widespread recommendations from health organisations encourage exclusive breastfeeding for six months. However, the addition of other fluids or foods before six months is common in many countries and communities. This practice suggests perceived benefits of early supplementation or lack of awareness of the possible risks.

Objectives

To assess the benefits and harms of supplementation for full‐term healthy breastfed infants and to examine the timing and type of supplementation.

Search methods

We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (21 March 2014) and reference lists of all relevant retrieved papers.

Selection criteria

Randomised or quasi‐randomised controlled trials in infants under six months of age comparing exclusive breastfeeding versus breastfeeding with any additional food or fluids.

Data collection and analysis

Two review authors independently selected the trials, extracted data and assessed risk of bias.

Main results

We included eight trials (984 randomised infants/mothers). Six trials (n = 613 analysed) provided data on outcomes of interest to this review. The variation in outcome measures and time points made it difficult to pool results from trials. Data could only be combined in a meta‐analysis for one secondary outcome (weight change). The trials that provided outcome data compared exclusively breastfed infants with breastfed infants who were allowed additional nutrients in the form of artificial milk, glucose, water or solid foods.

In relation to the majority of the older trials, the description of study methods was inadequate to assess the risk of bias. The two more recent trials, were found to be at low risk of bias for selection and detection bias. The overall quality of the evidence for the main comparison was low.

In one trial (170 infants) comparing exclusively breastfeeding infants with infants who were allowed additional glucose water, there was a significant difference favouring exclusive breastfeeding up to and including week 20 (risk ratio (RR) 1.45, 95% confidence interval (CI) 1.05 to 1.99), with more infants in the exclusive breastfed group still exclusively breastfeeding. Conversely in one small trial (39 infants) comparing exclusive breastfed infants with non‐exclusive breastfed infants who were provided with artificial milk, fewer infants in the exclusive breastfed group were exclusively breastfeeding at one week (RR 0.58, 95% CI 0.37 to 0.92) and at three months (RR 0.44, 95% CI 0.26 to 0.76) and there was no significant difference in the proportion of infants continuing any breastfeeding at three months between groups (RR 0.76, 95% CI 0.56 to 1.03).

For infant morbidity (six trials), one newborn trial (170 infants) found a statistically, but not clinically, significant difference in temperature at 72 hours (mean difference (MD) 0.10 degrees, 95% CI 0.01 to 0.19), and that serum glucose levels were higher in glucose supplemented infants in the first 24 hours, though not at 48 hours (MD ‐0.24 mmol/L, 95% CI ‐0.51 to 0.03). Weight loss was also higher (grams) in infants at six, 12, 24 and 48 hours of life in the exclusively breastfed infants compared to those who received additional glucose water (MD 7.00 g, 95% CI 0.76 to 13.24; MD 11.50 g, 95% CI 1.71 to 21.29; MD 13.40 g, 95% CI 0.43 to 26.37; MD 32.50 g, 95% CI 12.91 to 52.09), but no difference between groups was observed at 72 hours of life. In another trial (47 infants analysed), we found no significant difference in weight loss between the exclusively breastfeeding group and the group allowed either water or glucose water on either day three or day five (MD 1.03%, 95% CI ‐0.18 to 2.24) and (MD 0.20%, 95% CI ‐1.18 to 1.58).

Three trials with four‐ to six‐month‐old infants provided no evidence to support any benefit from the addition of complementary foods at four months versus exclusive breastfeeding to six months nor any risks related either morbidity or weight change (or both).

None of the trials reported on the remaining primary outcomes, infant mortality or physiological jaundice.

Authors' conclusions

We were unable to fully assess the benefits or harms of supplementation or to determine the impact from timing and type of supplementation.

We found no evidence of benefit to newborn infants and possible negative effects on the duration of breastfeeding from the brief use of additional water or glucose water, and the quality of the evidence from a small pilot study on formula supplementation was insufficient to suggest a change in practice away from exclusive breastfeeding. For infants at four to six months, we found no evidence of benefit from additional foods nor any risks related to morbidity or weight change. Future studies should examine the longer‐term effects on infants and mothers, though randomising infants to receive supplements without medical need may be problematic.

We found no evidence for disagreement with the recommendation of international health associations that exclusive breastfeeding should be recommended for healthy infants for the first six months.

PICOs

Population
Intervention
Comparison
Outcome

The PICO model is widely used and taught in evidence-based health care as a strategy for formulating questions and search strategies and for characterizing clinical studies or meta-analyses. PICO stands for four different potential components of a clinical question: Patient, Population or Problem; Intervention; Comparison; Outcome.

See more on using PICO in the Cochrane Handbook.

Plain language summary

Early additional food and fluids for healthy breastfed full‐term infants

Human milk provides for growth, protection and development for babies. It is important to the health of the mother. Exclusive breastfeeding is an infant's consumption of human milk with no supplementation of any type, including no water, juice, non‐human milk or foods. The effect of early supplementation may include decreased milk production due to reduced removal of milk from the breast, difficulties in developing effective breastfeeding and reduced confidence in the ability to breastfeed. Despite widespread recommendations supporting exclusive breastfeeding for six months, practice often does not appear to reflect these recommendations, thus suggesting there are perceived benefits from supplementation. We looked at studies on supplementation with additional fluids in the early weeks or supplementation with the addition of foods at four to six months of age. We identified eight randomised controlled studies involving 984 infants and their mothers that looked at exclusive breastfeeding compared with breastfeeding with additional fluids or foods.

From the trials we found, for the healthy breastfeeding baby in the first days after birth, two trials involving 217 infants found no evidence of benefit related to glucose levels, temperature, weight loss to newborn infants in giving additional water or glucose water. One of these trials (n = 170 analysed) found increased risk of early cessation of breastfeeding from the brief use of additional water or glucose water. One pilot study, with data from 39 infants who had lost over 5% of birthweight by 36 hours old provided evidence that small amounts of supplements in the first days might help breastfeeding to continue, though the trial researchers state there is insufficient evidence to recommend this as regular practice. For infants receiving supplements of food at four to six months, we did not find sufficiently high‐quality data from the three trials identified to indicate benefit to the infant in giving additional foods nor any risks related to either morbidity or weight change (or both).

The trials were reported on between 1982 and 2014. Two were carried out in Honduras, two in the USA and one in each of Spain, Nigeria, Iceland and the UK.

This review did not find evidence for disagreement with the recommendation of the World Health Organization and other international health associations that as a general policy exclusive breastfeeding, without additional foods or fluids, should be recommended for the first six months after birth.