SDTM Domain to Map Breastfeeding Data

Who is study subject?

Hi Priyanka, 

There is ML (Meal Data) standard domain introduced in SDTM IG 3.3.

However, a question is who is a consumer of breastfeeding and who is a study subject? If subjects of the study are babies, then you should utilize ML domain. If subjects of the study are mothers, then it would be some Findings or Events domain depends on Topic of the collected data.

Kind Regards, 

Sergiy

Babies are the study subject

Hi Sergiy,

Thank you so much for responding. The babies are the study subject and we also decided to have the data mapped to ML domain. 

The questions asked are :

1.Is the baby breastfed at all?   Yes/No  [MLOCCUR]

2.If No, date breastfeeding stopped .

3.Is the baby exclusively breastfed?

4.If No, date exclusive breastfeeding stopped.

In this case can you confirm where can we map question no 2,3,4?Also can we map MLTRT as "BREAST MILK"?

it sounds to me like you…

it sounds to me like you might need 2 records in ML - to cover feeding with BREAST MILK and FORMULA ?

if so, I would approach as follows:
MLTRT = BREAST MILK
MLPRESP = Y
MLOCCUR = Y/N = response to Q1
MLENDTC = response to Q2

MLTRT = FORMULA
MLPRESP = Y
MLOCCUR = Y/N = response to Q3, although response is inverted. i.e. exclusively breastfed = Y implies that Formula = N
MLSTDTC = response to Q4, i.e. formula starts on the date that exclusively breast milk stops

MLSTDTC for record where MLTRT=BREAST MILK

Hi,

Thank you so much for the response. The mapping makes sense :)

For MLTRT=BREAST MILK , can we map the Birthdate of the baby as MLSTDTC or should we keep it null?

Thanks,

Priyanka

Maybe - what if the baby was…

Maybe - what if the baby was born late at night and first feed is not until after midnight?

If you are not explictly collecting date/time of first feed I would probably leave null, and add a comment into sdrg

EX domain in Nutrition studies.

Hi Hi Priyanka, 

I've talked to other people of our team. It was an interesting comment, that babies breastfeeding data should be mapped into EX domain in Nutrition studies.

Kind Regards, 

Sergiy