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Trial record 13 of 38 for:    "sudden infant death"

Study of the Impact of Parental Note Taking on the Effectiveness of Anticipatory Guidance

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ClinicalTrials.gov Identifier: NCT01014169
Recruitment Status : Completed
First Posted : November 16, 2009
Results First Posted : October 19, 2012
Last Update Posted : October 19, 2012
Sponsor:
Collaborator:
The Joel and Barbara Alpert Endowment For The Children of The City
Information provided by (Responsible Party):
Boston Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Health Services Research
Conditions Health Education
Sudden Infant Death
Intervention Behavioral: Note taking
Enrollment 126
Recruitment Details Mothers on the postpartum ward of an urban safety-net hospital were recruited. Inclusion criteria included gestational age > 35 weeks, fluency in English or Spanish, and access to a telephone. Mothers were excluded if there was prolonged hospitalization of the mother or the infant or if they were not expected to retain custody of the infant.
Pre-assignment Details  
Arm/Group Title Usual Care Note Taking
Hide Arm/Group Description Mothers in the control group received newborn information from the nurse practitioner [sometimes via a Spanish interpreter, if required] according to current standard of care, which includes verbal information and written handouts. The mothers in the intervention group were given a pen and paper and encouraged to take written notes using their language of preference when receiving the standard newborn information.
Period Title: Overall Study
Started 65 61
Completed 58 48
Not Completed 7 13
Arm/Group Title Usual Care Note Taking Total
Hide Arm/Group Description Mothers in the control group received newborn information from the nurse practitioner [sometimes via a Spanish interpreter, if required] according to current standard of care, which includes verbal information and written handouts. The mothers in the intervention group were given a pen and paper and encouraged to take written notes using their language of preference when receiving the standard newborn information. Total of all reporting groups
Overall Number of Baseline Participants 65 61 126
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 65 participants 61 participants 126 participants
27.8  (6.5) 28.9  (6.4) 28.3  (6.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 61 participants 126 participants
Female
65
 100.0%
61
 100.0%
126
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 61 participants 126 participants
Hispanic or Latino
31
  47.7%
32
  52.5%
63
  50.0%
Not Hispanic or Latino
34
  52.3%
29
  47.5%
63
  50.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 61 participants 126 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
6
   9.2%
2
   3.3%
8
   6.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
22
  33.8%
20
  32.8%
42
  33.3%
White
7
  10.8%
9
  14.8%
16
  12.7%
More than one race
30
  46.2%
30
  49.2%
60
  47.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Language  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 65 participants 61 participants 126 participants
English 37 36 73
Spanish 28 25 53
Number of pregnancies  
Median (Inter-Quartile Range)
Unit of measure:  Pregnancies
Number Analyzed 65 participants 61 participants 126 participants
2
(2 to 2)
2
(2 to 2)
2
(2 to 2)
Number of Children  
Median (Inter-Quartile Range)
Unit of measure:  Children
Number Analyzed 65 participants 61 participants 126 participants
2
(2 to 2)
2
(1 to 2)
2
(2 to 2)
Type of delivery  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 65 participants 61 participants 126 participants
Vaginal 46 46 92
Cesarean section 19 15 34
Type of Insurance  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 65 participants 61 participants 126 participants
Medicaid 52 46 98
Free Care 5 3 8
Private 7 11 18
None 1 1 2
Highest Education Level  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 65 participants 61 participants 126 participants
Less than/some high school 24 14 38
High school graduate 15 21 36
Vocational/trade school 1 2 3
Some college 9 11 20
Associates degree 5 1 6
Bachelors degree 7 7 14
Graduate/professional degree 4 5 9
Received prenatal care  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 65 participants 61 participants 126 participants
Yes 65 61 126
No 0 0 0
Attended Childbirth Classes  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 65 participants 61 participants 126 participants
Yes 10 12 22
No 55 49 104
Other Adults in the Home  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 65 participants 61 participants 126 participants
No other adult in home 9 8 17
Spouse/partner 43 44 87
Baby's grandmother 10 12 22
Baby's grandfather 6 4 10
Baby's uncles or aunts 17 11 28
Other adult 2 2 4
Nurse Practitioner  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 65 participants 61 participants 126 participants
Patients Seen By Nurse Practitioner # 1 37 34 71
Patients Seen By Nurse Practitioner # 2 21 22 43
Patients Seen By Nurse Practitioner # 3 7 5 12
1.Primary Outcome
Title The Primary Outcome of Interest is Maternal Practice Related to Supine Infant Sleep Position.
Hide Description This measure assesses maternal report of placing the infant on the back to sleep (supine sleep position) as opposed to putting the infant on its side or stomach.
Time Frame two days after discharge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Note Taking
Hide Arm/Group Description:
Mothers in the control group received newborn information from the nurse practitioner [sometimes via a Spanish interpreter, if required] according to current standard of care, which includes verbal information and written handouts.
The mothers in the intervention group were given a pen and paper and encouraged to take written notes using their language of preference when receiving the standard newborn information.
Overall Number of Participants Analyzed 58 48
Measure Type: Number
Unit of Measure: participants who report supine position
45 42
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care, Note Taking
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.13
Confidence Interval (2-Sided) 95%
0.95 to 1.34
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Maternal Practice Related to Breastfeeding Initiation
Hide Description This measure assesses maternal report of breastfeeding. The number analyzed is the number who reported any breastfeeding.
Time Frame two days after discharge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Note Taking
Hide Arm/Group Description:
Mothers in the control group received newborn information from the nurse practitioner [sometimes via a Spanish interpreter, if required] according to current standard of care, which includes verbal information and written handouts.
The mothers in the intervention group were given a pen and paper and encouraged to take written notes using their language of preference when receiving the standard newborn information.
Overall Number of Participants Analyzed 58 48
Measure Type: Number
Unit of Measure: participants who report breastfeeding
50 46
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care, Note Taking
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.11
Confidence Interval (2-Sided) 95%
0.99 to 1.25
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Maternal Practice Related to Correct Car Seat Use
Hide Description Correct car seat use by all subjects who use cars was defined as placing the car seat in the back seat facing backwards and using the car seat every time the infant travels by car. The number reported is the number who report using the car seat correctly.
Time Frame two days after discharge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Note Taking
Hide Arm/Group Description:
Mothers in the control group received newborn information from the nurse practitioner [sometimes via a Spanish interpreter, if required] according to current standard of care, which includes verbal information and written handouts.
The mothers in the intervention group were given a pen and paper and encouraged to take written notes using their language of preference when receiving the standard newborn information.
Overall Number of Participants Analyzed 55 46
Measure Type: Number
Unit of Measure: participants with correct car seat use
48 46
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care, Note Taking
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.12
Confidence Interval 95%
1.00 to 1.25
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Usual Care Note Taking
Hide Arm/Group Description Mothers in the control group received newborn information from the nurse practitioner [sometimes via a Spanish interpreter, if required] according to current standard of care, which includes verbal information and written handouts. The mothers in the intervention group were given a pen and paper and encouraged to take written notes using their language of preference when receiving the standard newborn information.
All-Cause Mortality
Usual Care Note Taking
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Usual Care Note Taking
Affected / at Risk (%) Affected / at Risk (%)
Total   0/65 (0.00%)   0/61 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Usual Care Note Taking
Affected / at Risk (%) Affected / at Risk (%)
Total   0/65 (0.00%)   0/61 (0.00%) 
Conducted as a pilot study and not powered to demonstrate a significant difference between the two groups; subjects and NPs were aware of the group assignment; outcomes were determined using maternal self report.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr Caroline Kistin
Organization: Boston University School of Medicine/Boston Medical Center
Phone: 617-414-3642
Publications:
Kendall J. Suzuki's Mother Tongue Method. Music Educators Journal. 1986;72:47-50
Creech A and Hallam S. Parent-teacher-pupil interactions in instrumental music tuition: a literature review. B.J. Music Ed. 2003;20:29-44.
Grilli S. An interview with Dr. Shin'ichi Suzuki at the Talent Education Institute. International Review of Education. 1992; 38: 547-551.
Intons-Peterson MJ, Fournier J. External and Internal Memory Aids: When and How Often Do We Use Them? Journal of Experimental Psychology: General. 1986;115:267-280.
Kiewra KA DuBois NF, McShane CD, et al. Note-taking functions and techniques. Journal of Educational Psychology. 1991;83:240-245.
Andrade J. What Does Doodling Do? Appl Cognit Psychol.2009;23:1-7.
2008. Bright Futures: Guidelines for Health Supervision of Infants, Children, and Adolescents, Third Edition. Elk Grove Village, IL: American Academy of Pediatrics.
United States Preventative Services Task Force: Recommendations of Breastfeeding Counseling. www.ahrq.gov/clinic/uspstf/uspsbrfd.htm. Accessed on 11/25/08.
Responsible Party: Boston Medical Center
ClinicalTrials.gov Identifier: NCT01014169     History of Changes
Other Study ID Numbers: H-28356
First Submitted: November 13, 2009
First Posted: November 16, 2009
Results First Submitted: August 20, 2012
Results First Posted: October 19, 2012
Last Update Posted: October 19, 2012