NCT01321710

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
152

participants targeted

Target at P50-P75 for not_applicable pregnancy

Timeline
Completed

Started Dec 2004

Typical duration for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

March 22, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 23, 2011

Completed
11 months until next milestone

Results Posted

Study results publicly available

February 29, 2012

Completed
Last Updated

February 29, 2012

Status Verified

January 1, 2012

Enrollment Period

3.4 years

First QC Date

March 22, 2011

Results QC Date

August 22, 2011

Last Update Submit

January 27, 2012

Conditions

PregnancyPostpartum PeriodSleep Disturbance

Keywords

sleep hygieneactigraphymaternalinfantpostpartum periodimmunizationacetaminophen

Outcome Measures

Primary Outcomes (3)

  • Maternal Sleep Quantity (Objective)

    Maternal sleep quantity is defined as total night-time sleep in hours as measured by wrist actigraphy over 3 nights.

    1-month postpartum (approximately)

  • Maternal Sleep Quality (Objective)

    Maternal sleep quality is defined as sleep efficiency (percent sleep per time in bed averaged across 3 nights) as measured by wrist actigraphy.

    1 month postpartum (approximately)

  • Change in Infant Sleep Quantity (Objective)

    Change in infant sleep quantity is defined as the difference between the number of hours slept in the 24 hours prior to immunization and the the number of hours slept after immunization (positive numbers indicate more sleep following immunization). Infant sleep was measured by ankle actigraphy.

    24 hours before and 24 hours after immunizations at approximately 2 months of age

Secondary Outcomes (2)

  • Maternal Sleep Disturbance (Subjective)

    1 month postpartum (approximately)

  • Maternal Well-being

    1 month postpartum (approximately)

Study Arms (3)

Dietary information & standard care

ACTIVE COMPARATOR

Mothers in this arm receive dietary information aimed at reducing postpartum sleep disturbance. Infants in this arm receive no intervention beyond standard immunization care.

Behavioral: Dietary information

Sleep hygiene & standard care

EXPERIMENTAL

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

Behavioral: Sleep hygiene

Sleep hygiene & acetaminophen

EXPERIMENTAL

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.

Behavioral: Sleep hygieneDrug: Acetaminophen

Interventions

Sleep hygieneBEHAVIORAL

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.

Sleep hygiene & acetaminophenSleep hygiene & standard care
Dietary informationBEHAVIORAL

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.

Dietary information & standard care
AcetaminophenDRUG

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.

Sleep hygiene & acetaminophen

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • pregnant women expecting first singleton birth
  • able to speak, read, and write in English
  • willing to participate for 3 consecutive days and nights during 36-39 weeks gestation and at 4, 8, and 12 weeks postpartum
  • willing to have their infant participate in ankle actigraphy recording of their sleep/wake patterns for 96 hrs at the time of their first immunization

You may not qualify if:

  • history of affective illness prior to pregnancy
  • current use of medications that may alter sleep
  • history of a diagnosed sleep disorder such as sleep apnea, nocturnal myoclonus, or narcolepsy
  • plan to employ live-in help with child care
  • working the night-shift
  • multiple pregnancy with twins or more

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California

San Francisco, California, 94143-0606, United States

Location

Related Publications (4)

  • Lee KA, Gay CL. Can modifications to the bedroom environment improve the sleep of new parents? Two randomized controlled trials. Res Nurs Health. 2011 Feb;34(1):7-19. doi: 10.1002/nur.20413. Epub 2010 Nov 17.

    PMID: 21243655RESULT

  • Goyal D, Gay C, Lee KA. How much does low socioeconomic status increase the risk of prenatal and postpartum depressive symptoms in first-time mothers? Womens Health Issues. 2010 Mar-Apr;20(2):96-104. doi: 10.1016/j.whi.2009.11.003. Epub 2010 Feb 4.

    PMID: 20133153RESULT

  • Kennedy HP, Gardiner A, Gay C, Lee KA. Negotiating sleep: a qualitative study of new mothers. J Perinat Neonatal Nurs. 2007 Apr-Jun;21(2):114-22. doi: 10.1097/01.JPN.0000270628.51122.1d.

    PMID: 17505231RESULT

  • Franck L, Gay CL, Lynch M, Lee KA. Infant sleep after immunization: randomized controlled trial of prophylactic acetaminophen. Pediatrics. 2011 Dec;128(6):1100-8. doi: 10.1542/peds.2011-1712. Epub 2011 Nov 28.

    PMID: 22123869DERIVED

MeSH Terms

Conditions

ParasomniasSleep Hygiene

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Sleep Wake DisordersNervous System DiseasesMental DisordersHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Results Point of Contact

Title
Kathryn Lee, RN, PhD
Organization
University of California, San Francisco
kathryn.lee@nursing.ucsf.edu
415-476-4442

Study Officials

  • Kathryn A. Lee, RN, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2011

First Posted

March 23, 2011

Study Start

December 1, 2004

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

February 29, 2012

Results First Posted

February 29, 2012

Record last verified: 2012-01

Locations

US(1)