Is the apparently protective effect of maternal nicotine replacement therapy (NRT) used in pregnancy on infant development explained by smoking cessation?: secondary analyses of a randomised controlled trial.

What Was Tested

This randomized controlled trial looks at Therapeutic nicotine (patch, non-peptide).

To investigate relationships between maternal smoking status in pregnancy and infant development.

Surprisingly, infants born to women randomised to NRT were more likely to have unimpaired development at 2 years.

The researchers hypothesised that this apparently protective effect was due to smoking cessation caused by NRT and so, investigate this relationship using the same cohort.

Who Took Part

The age groups tagged for this paper are infants, young adults and adults, women only.

Participants' smoking behaviour were recorded at randomisation, 1 month after their target quit date and at delivery.

Using logistic regression models, the researchers investigated associations between participants' smoking measures and infant development (assessed using the Ages and Stages questionnaire) at 2 years.

How the Study Was Run

The researchers set it up as a randomized and placebo-controlled study.

Random assignment meant chance, not the researchers, decided who got Therapeutic nicotine (patch, non-peptide) and who got the comparison, which limits bias.

A placebo (an inactive look-alike) gave the Therapeutic nicotine (patch, non-peptide) group a baseline to be compared against.

Secondary analysis of a randomised controlled trial.

Seven antenatal hospitals in the Midlands and North-West England.

Eight hundred and eighty-four pregnant smokers randomised to receive either NRT patches or visually-identical placebo in the SNAP trial.

What Was Measured

PubMed files the paper under topics including Child Development, England, Logistic Models, Nicotine, Outcome Assessment, Health Care, Pregnancy Complications and Pregnancy Outcome.

Author keywords: developmental impairment, maternal smoking and smoking in pregnancy.

What This Means in Plain Language

The paper is a randomized and placebo-controlled study of Therapeutic nicotine (patch, non-peptide).

Results are reported in around 3 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2019 (BMJ open), a journal based in England.

More context: the Therapeutic nicotine (patch, non-peptide) compound page, all human trials.