Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2R01NR005345 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleep hygiene | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal Sleep Disturbance (Subjective) | Maternal sleep disturbance is measured by the total score on the General Sleep Disturbance Scale (GSDS). The GSDS is a self-report questionnaire that measures perceived sleep disturbance in the past week. GSDS scores range from 0 to 147, with higher scores indicating more sleep disturbance. | 1 month postpartum (approximately) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kathryn A. Lee, RN, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California | San Francisco | California | 94143-0606 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21243655 | Result | 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. | |
| 20133153 | Result | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Dietary Information & Standard Care | Mothers in this arm receive dietary information aimed at reducing postpartum sleep disturbance. Infants in this arm receive standard immunization care. |
| FG001 | Sleep Hygiene & Standard Care | Mothers in this arm receive a sleep hygiene intervention aimed at improving their postpartum sleep. Infants in this arm receive standard immunization care. |
| FG002 | Sleep Hygiene & Acetaminophen | Mothers in this arm receive a sleep hygiene intervention aimed at improving postpartum sleep. Infants in this arm receive an acetaminophen intervention to minimize sleep disturbance following immunization. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Dietary Information & Standard Care | Mothers in this arm receive dietary information aimed at reducing postpartum sleep disturbance. Infants in this arm receive standard immunization care. |
| BG001 | Sleep Hygiene & Standard Care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maternal Sleep Quantity (Objective) | Maternal sleep quantity is defined as total night-time sleep in hours as measured by wrist actigraphy over 3 nights. | ITT analysis. Because this was a repeated measures analysis at 1 and 3 months postpartum, subjects missing outcome data at either point were excluded from the analysis. | Posted | Mean | Standard Deviation | hours | 1-month postpartum (approximately) |
|
4 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dietary Information & Standard Care | Mothers in this arm receive dietary information aimed at reducing postpartum sleep disturbance. Infants in this arm receive standard immunization care. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kathryn Lee, RN, PhD | University of California, San Francisco | 415-476-4442 | kathryn.lee@nursing.ucsf.edu |
Not provided
| ID | Term |
|---|---|
| D020447 | Parasomnias |
| D000070263 | Sleep Hygiene |
| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D015438 | Health Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Dietary information | Behavioral | 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. |
|
| Acetaminophen | Drug | 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. |
|
| Maternal Well-being | Maternal well-being was measured by the total score on the Center for Epidemiologic Studies - Depression Scale (CES-D). The CES-D measures depressive symptoms in the past week. CES-D scores can range 0 to 60, with higher scores indicating more symptoms of depression. | 1 month postpartum (approximately) |
| 17505231 | Result | 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. |
| 22123869 | Derived | 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. |
Mothers in this arm receive a sleep hygiene intervention aimed at improving their postpartum sleep.
Infants in this arm receive standard immunization care.
| BG002 | Sleep Hygiene & Acetaminophen | Mothers in this arm receive a sleep hygiene intervention aimed at improving postpartum sleep. Infants in this arm receive an acetaminophen intervention to minimize sleep disturbance following immunization. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | 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. | ITT analysis. Because this was a repeated measures analysis at 1 and 3 months postpartum, subjects missing outcome data at either point were excluded from the analysis. | Posted | Mean | Standard Deviation | percentage of sleep per time in bed | 1 month postpartum (approximately) |
|
|
|
| Secondary | Maternal Sleep Disturbance (Subjective) | Maternal sleep disturbance is measured by the total score on the General Sleep Disturbance Scale (GSDS). The GSDS is a self-report questionnaire that measures perceived sleep disturbance in the past week. GSDS scores range from 0 to 147, with higher scores indicating more sleep disturbance. | ITT analysis. | Posted | Mean | Standard Deviation | Scores on a scale | 1 month postpartum (approximately) |
|
|
|
| Secondary | Maternal Well-being | Maternal well-being was measured by the total score on the Center for Epidemiologic Studies - Depression Scale (CES-D). The CES-D measures depressive symptoms in the past week. CES-D scores can range 0 to 60, with higher scores indicating more symptoms of depression. | ITT analysis. | Posted | Mean | Standard Deviation | Scores on a scale | 1 month postpartum (approximately) |
|
|
|
| Primary | 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. | ITT analysis. Infants who were not immunized or did not have valid outcome data were excluded from the analysis. | Posted | Mean | Standard Deviation | minutes | 24 hours before and 24 hours after immunizations at approximately 2 months of age |
|
|
|
| 0 |
| 44 |
| 0 |
| 44 |
| EG001 | Sleep Hygiene & Standard Care | Mothers in this arm receive a sleep hygiene intervention aimed at improving their postpartum sleep. Infants in this arm receive standard immunization care. | 0 | 58 | 0 | 58 |
| EG002 | Sleep Hygiene & Acetaminophen | Mothers in this arm receive a sleep hygiene intervention aimed at improving postpartum sleep. Infants in this arm receive an acetaminophen intervention to minimize sleep disturbance following immunization. | 0 | 50 | 0 | 50 |
Not provided
Not provided
| D001519 |
| Behavior |
| Aniline Compounds |
| D000588 | Amines |