Conditions: Pregnancy Postpartum Period Sleep Disturbance
Keywords: sleep hygiene actigraphy maternal infant postpartum period immunization acetaminophen
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 152
Healthy volunteers: no

Brief summary:
The purpose of this study is to test a behavioral intervention to minimize sleep disruption and fatigue in new mothers after the birth of their first infant. This study also tests whether an acetaminophen intervention at the time of an infant's 2-month immunization series improves infant and maternal sleep.

Detailed description:

Arms:
arm 1: Mothers in this arm receive dietary information aimed at reducing postpartum sleep disturbance.

Infants in this arm receive no intervention beyond standard immunization care. arm 2: Mothers in this arm receive a sleep hygiene intervention aimed at improving their postpartum sleep.

Infants in this arm receive standard immunization care. arm 3: Mothers in this arm receive a sleep hygiene intervention aimed at improving postpartum sleep.

Infants in this arm receive an acetaminophen intervention (12.5mg per kg infant weight, 1 dose 30 minutes prior to immunization and q4-6h thereafter, for a total of 5 doses) to minimize sleep disturbance following immunization.

Interventions: intervention 1: Sleep hygiene intervention 2: Dietary information intervention 3: Acetaminophen
Intervention descriptions: intervention 1: This intervention consists of behavioral strategies for minimizing maternal arousal and sleep disturbance as a result of night-time infant care. Key components include: infant proximity, low lighting, and noise attenuation.

It is administered to women during their last month of pregnancy. intervention 2: This intervention consists of dietary information aimed at improving postpartum sleep. The recommendations include avoiding alcohol, caffeine, and heavy meals before bed, as well as eating healthy foods. intervention 3: 51-90mg depending on infant weight (12.5mg per kg infant weight). Administered 30 minutes prior to immunization and q4-6h for a total of 5 doses.

Protocol document: