Was consent sought before offering premature babies formula or fortifier in UK NICUs? Results of a facebook survey. March 2018 Kathryn Stagg IBCLC


This survey was designed to find out whether UK families with babies in special care who were born before 34 weeks gestation were asked for consent before their babies were offered cows’ milk based infant formula top ups or cows’ milk based fortifier and whether the risks were discussed. The motivation behind this study was a reply on a Facebook post from a mother who lost one of her premature twins to NEC (Necrotising enterocolitis) after he was given cows’ milk based fortifier without her consent. She is quite certain that the fortifier had something to do with the baby developing this deadly disease, although there is little formal research to this back this up. However, there is quite extensive research into the risks of developing NEC when babies are fed with cows’ milk based infant formula. More studies into the risks of cow’s milk based fortifier are desperately needed to ensure parents can make an informed choice. One study found no significant risk of NEC whereas another found there was an increased risk. Studies are summarised here: https://bestbets.org/bets/bet.php?id=2309

Fortifiers are made from processed cows’ milk protein with added nutritional supplements. It is often offered to premature babies as studies have shown that breast milk alone does not contain enough of the energy, protein, vitamins, minerals and salts needed by rapidly growing premature infants. There seems less risk of fortifier triggering CMPA (Cows’ Milk Protein Allergy) due to the proteins being hydrolysed.

Studies into the effects of infant formula on the development of NEC are summarised in this article from UNICEF: https://www.unicef.org.uk/babyfriendly/news-and-research/baby-friendly-research/infant-health-research/infant-health-research-necrotising-enterocolitis/

Infant formula, also processed cows’ milk, is often offered to babies where the mum is struggling to meet the required amounts of pumped breast milk, or if baby is struggling to gain weight on solely breast milk then high calorie formula can be used to help. A significant association between early neonatal exposure to cow’s milk formula feeding and subsequent development of CMPA/CMPI has been documented.  https://onlinelibrary.wiley.com/doi/pdf/10.1111/j.1399-3038.1994.tb00352.x

The survey was an anonymous exploratory study and shared on the “Breastfeeding Twins and Triplets UK” Facebook group and the “Parents of Preemies UK” Facebook groups. Those who took part were free to choose to participate and were aware anonymous quotes may be used. 191 parents responded, 131 had singletons, 54 had twins, 6 had triplets, so that equals 257 babies in total.

Gestation in weeks                            

<25+9 9% 17
26+0 – 27+6 19% 36
28+0 – 29+6 24% 44
30+0 – 31+6 19% 37
32+0 – 33+6 30% 57

During their time in NICU these babies were given the following:

Donor milk 23% 43
Fortifier 64% 123
Formula 52% 99
Just breast milk 19%           36

This is how the rate of supplementation varied for different gestation babies.

(gestation in wks) <25+9 26+0 – 27+6 28+0 – 29+6 30+0 – 31+6 32+0 – 33+6
Donor milk 29% 22% 25% 35% 11%
Fortifier 94% 86% 82% 57% 32%
Formula 35% 50% 36% 49% 72%

Before your baby/ies were given formula or fortifier was consent sought and were risks explained?

No consent sought 31% 58
Consent sought/no risks discussed 44% 81
Consent sought/few risks discussed 15% 27
Consent sought/full risks discussed 10% 19

Was donor milk discussed and consent sought?

Not offered 68% 126
discussed/no consent 3% 6
discussed/consent 29% 54

As this survey covered from very early babies up to 34 week gestation one would imagine that the majority of time donor milk was not offered was for the later babies. However on further analysis, 50% of the babies less than 26 weeks, nearly 65% of babies between 26 and 28 weeks and over 60% of babies around 60% of 28-32 week babies were not offered access to donor milk.

I was also interested by the difference in numbers where consent was sought between formula/fortifier and donor milk. Perhaps donor milk is deemed far more risky than formula and fortifier? In reality, I am not sure this is the case.

Here are some quotes from the survey:

I was very clear that I wanted to breastfeed only but they asked me to consent to formula in case it was needed before I managed to harvest colostrum. No discussion about the risks of formula or the importance of breast milk. If I hadn’t been aware already I might not have understood the benefits of breast milk for premature babies.

Both my babies were prem. I had to fight to give my son my milk. They gave him formula without my consent. With my daughter I actually had a NICU nurse tell me that I would fail at breastfeeding and shouldn’t even bother trying! It broke my heart.

I felt pressured into giving fortifier by the dietitian even though the nurses informed me that they didn’t like to give it to babies, none of them would give me enough info as to why as they didn’t want to be seen as disagreeing with another member of staff (the dietitian) All my boys now have CMPA and I’m wondering if there’s a link.

I wish more units allowed donor milk – it’s so important.

When I had my 26 weeker I expressed for a while and one day I came in and my milk was getting something put in and all I was told it was fortifier he needed it and that was it.

Twin one was given formula on day one as nurses said he needed feeding, went on to solely breastmilk about day three then on to fortified breast milk shortly after. Twin two was given breast milk until he was on full feeds then given fortifier on day 9. Day 10 twin 2 became very ill with NEC and died within hours.

Was NEC (Necrotising enterocolitis) discussed with you?

Yes 30% 57
No 70% 132

NEC was only discussed with 30% of the families. Again maybe this low figure was due to the older age range, but on further analysis NEC was discussed only with between 30-40% of parents with babies born in the higher risk zones of 26-32 weeks gestation, rising to 50% of families with babies of less than 26 weeks gestation. 

Conclusion:

Although the risks of fortifier are still unclear, consent should always be sought and use discussed before babies are given it. The risks of giving formula are much more apparent; increased risk of NEC and development of CMPA and yet still it seems that consent is not always sought before it is given to babies. For 31% of the babies on this survey, consent was not sought. This needs to change.