Effect of nicotine patches in pregnancy on infant and maternal outcomes at 2 years: follow-up from the randomised, double-blind, placebo-controlled SNAP trial.

What Was Tested

Researchers studied Therapeutic nicotine (patch, non-peptide) in this randomized controlled trial publication.

To assess whether NRT use in pregnancy might cause harm to infants, the researchers aimed to compare effects of NRT and placebo on infant development 2 years after delivery.

Why It Was Studied

Subsequent effects of NRT on the children of treated mothers are unknown because no trials have investigated the effect of gestational NRT use beyond birth.

National Institute for Health Research Health Technology Assessment Programme.

Who Took Part

The study group was 2 infants.

PubMed indexes the participants as infants, young children, teenagers, young adults and adults, women only.

Randomisation was stratified by site with participants, health-care professionals, and research staff masked to treatment allocation.

The primary results for participants and infants at delivery were published in 2012; the researchers present results from the trial cohort 2 years after birth.

How the Study Was Run

The researchers set it up as a randomized, double-blind 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.

As a double-blind Therapeutic nicotine (patch, non-peptide) study, the assignments were hidden from both participants and investigators until the end.

The comparison arm used a placebo, so changes seen with Therapeutic nicotine (patch, non-peptide) could be set against what happens without it.

After delivery, questionnaires were posted to participants and, if there was no response, to family physicians.

The primary outcome at 2 years was infants' survival without developmental impairment (ie, no disability or problems with behaviour or development).

Treatment groups were compared on an intention-to-treat basis.

The trial is registered with Controlled-Trials.com, number ISRCTN07249128.

What Was Measured

National Institute for Health Research Health Technology Assessment Programme.

Topics PubMed links to this paper include England, Intention to Treat Analysis, Outcome Assessment, Health Care, Pregnancy Complications, Pregnancy Outcome, Prenatal Exposure Delayed Effects and Smoking Cessation.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Therapeutic nicotine (patch, non-peptide) in 2 infants.

With fewer than 40 people, it is a small study, so it is better read as an early signal for further research than as a settled answer.

The abstract goes on to report its results in about 8 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2014 (The Lancet. Respiratory medicine), a journal based in England.

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