Intranasal Oxytocin and Maternal Neglect

What Was Tested

In this not phased trial, researchers set out to test Oxytocin.

The investigators plan to conduct functional MRI scanning with a group of mothers who are blindly and randomly assigned either intranasal oxytocin or a placebo.

The purpose of this investigation is to explore how oxytocin may modify early maternal brain and behavioral responses to infant cues.

It had two arms (groups): Oxytocin (experimental) and Placebo (experimental).

Intranasal placebo spray given 50 minutes prior to behavior assessment or scanning.

The registry classes the interventions as drug and procedure.

More on the Plan

The investigators plan to conduct fMRI scanning with a group of mothers who are blindly and randomly assigned either intranasal oxytocin or a placebo.

Aim 1: To determine whether intranasal oxytocin (IN-OT) affects parental brain responses to infant cues, as measured during functional MRI (fMRI) scanning.

Aim 2: To determine whether IN-OT affects parental behavioral responses to infant cues, as measured by videotaped parent-infant interaction procedures.

Aim 3: To determine whether attachment security interacts with the effect of IN-OT on maternal brain and behavioral responses to infant cues.

Who Took Part

132 actual participants took part.

It was open to people of any sex aged from 20 years up to 45 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Be first-time parent(s). Who have just delivered a term infant \>37 weeks gestation, without medical complications. Aged between 20 and 45 years;. And be English speaking from childhood (required for accurate coding of attachment interview). Have female partners who just delivered a term infant \>37 weeks gestation, without medical complications;.

The full record lists 8 inclusion and 5 exclusion criteria; among the exclusions: history of head injury resulting in loss of consciousness for \>10 minutes;; neurological disease, including stroke, brain tumor, meningitis or encephalitis;; any contraindications to mri scanning, e.g. pacemakers, aneurysm clips, neurostimulators, fixed hearing devices, metal in eyes, or other implants;.

How the Study Was Run

The set-up was randomized, crossover and double-blind.

Random assignment meant chance, not the researchers, decided who got Oxytocin and who got the comparison, which limits bias.

Each person switched between Oxytocin and the comparison at some point, usually with a gap in between.

Neither the participants nor the staff measuring them knew who was on Oxytocin, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2010-05 with completion listed for 2019-03.

It ran at 2 sites in United States (2).

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Differences in Brain Activation (Blood Oxygen Level Dependent [BOLD] Signal) of Dopamine Reward Regions and Prefrontal Cortex After Intranasal Oxytocin Administration in Mothers (time frame: 30 minutes after intranasal spray is administered).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 132 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Oxytocin compound page, all human trials.