Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| K23HD065872 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Excessive infant crying (EIC) is likely to increase the risk of child abuse. The investigators propose a randomized trial using an intervention based on recommendations of Karp. The investigators will systematically identify 170 term infants with EIC and conduct assessments in the home at 6-8 weeks age to test the hypothesis that the intervention reduces mean infant hours of night-time crying, increases maternal soothing behaviors and improves parental anxiety and depression.
Hypotheses: The soothing techniques taught to study parents 2-3 wks after birth augment parental soothing skills and reduces infant crying at night (primary outcome) and parental sleep loss, distress, & depression assessed in the home by a masked nurse at 8 wks.
Methods: Term singleton infants with EIC (> 3 hrs/24h) recruited through a program offered to parents at our hospital (4,700 births/yr) will be seen in our clinic 2-3 wks after birth. Consenting families (n=178) will be randomized to standard colic counseling (American Academy of Pediatrics) or to the intervention (adding nurse instruction plus a video and pamphlets). At 8 wks a study nurse will assess parental sleep and distress (Brief Symptom Inventory-18), place dosimeters in rooms where the infant sleeps and spends most time, and apply the actigraph at the ankle. She will collect the devices 5 days later, perform a physical exam at a usual feeding time (when EIC is likely), record infant & maternal behaviors during crying/feeding for the next 15 minutes using unobtrusive, validated methods (Tyson, 1992), and provide maternal support if desired. Standard statistical tests will be used (alpha=0.05; beta = 0.20; effect size =0.5 SD, power = .90).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The Happiest Baby on The Block | Experimental | Those receiving the intervention will be trained in the infant soothing techniques outlined in "The Happiest Baby on the Block". |
|
| AAP Education | Active Comparator | Those receiving the control group allocation will be counseled in the American Academy of Pediatrics guidelines regarding Infant Colic (AAP Infant Colic counseling). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The Happiest Baby on The Block | Behavioral | Those receiving the intervention will be trained in the infant soothing techniques outlined in "The Happiest Baby on the Block". |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean night-time crying | Objectively recording night-time duration of excessive crying | 2 weeks after enrollment. Appproximately 6-8 weeks of life. |
| Mean sleep duration | objectively measuring infant sleep duration | 2 weeks after enrollment. Appproximately 6-8 weeks of life. |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal Depression, Anxiety and Somatization | Using the BSI-18 at study enrollment and conclusion. | At study entry and conculsion (4 week interval); 2 weeks after enrollment. Appproximately 6-8 weeks of life. |
| Salivary Biomarkers |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
Not provided
| Label | URL |
|---|---|
| American Academy of Pediatrics Infant Colic Website | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D003085 | Colic |
| D019052 | Depression, Postpartum |
| D038642 | Shaken Baby Syndrome |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D011644 | Puerperal Disorders |
| D011248 | Pregnancy Complications |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| AAP Infant Colic counseling | Behavioral | Those receiving the control group allocation will be counseled using the American Academy of Pediatrics material for Infant Colic. |
|
We are collecting maternal salivary cortisol and amylase at study entry and at study conclusion (within 2 weeks after enrollment)
| At Study Entry and at 2 weeks after enrollment |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001930 | Brain Injuries |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D009422 | Nervous System Diseases |
| D014947 | Wounds and Injuries |